Exercise With Individual Dosage Against the Best Current Practice in Lower Limb Tendinopathy (MaLaGa Trial)

Tendinopathy Clinical Trial

— MaLaGa  

Official title:

Effect of a Common Exercise Programme With an Individualized Progression Criterion Based on the Measurement of Neuromuscular Capacity Versus Eccentric Training for Lower Limb Tendinopathies (MaLaGa Trial): Randomised Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03853122
• Other study ID #: DOSIS&TENDON
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Half of the participants will receive the experimental intervention, while the other half will receive the best current practice.

Description:

The current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by Cook and Purdam (Cook & Purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (Mellor et al., 2018). However, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities.

Therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. Moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;

2. Pain duration for at least one month.

Exclusion Criteria:

1. Corticosteroid injection in the studied tendon in the last 12 months;

2. Other injuries in the affected lower limb in the last 12 months;

3. Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;

4. Tendinous rupture history in the affected lower limb;

5. Systemic diseases such as rheumatic arthritis or diabetes mellitus.

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Other:
• Best current practice exercise programme
Therapeutic Physical Exercise programme based on the protocol of Afredson (for Achilles and patellar tendinopathies) and LEAP (for gluteal tendinopathy). Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetitions of two eccentric exercises Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetions of one eccentric exercise Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL: an exercise programme divided into stages with progression in different exercises, volumes and loads
• Experimental exercise programme
Therapeutic Physical Exercise programme structured in five stages oriented to specific neuromuscular adaptations based on the characteristics of the neuromuscular system, once daily, three times/week, sets, repetitions and load based on individually performed tests.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Ministry of Science, Innovation and Universities, Spain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Victorian Institute of Sport Assessment (VISA) questionnaire POST	Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Victorian Institute of Sport Assessment (VISA) questionnaire PRE	Visa-A model for Achilles tendon, Visa-P model for Patellar tendon, Visa-G model for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).	Baseline, 1 week before start of the intervention
Secondary	Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM	Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).	Short term, 7 weeks after start of the intervention
Secondary	Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up	Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).	52 weeks after the start of the intervention
Secondary	Central Sensitization Inventory (CSI) PRE	Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)	Baseline, 1 week before start of the intervention
Secondary	Central Sensitization Inventory (CSI) SHORT TERM	Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)	Short term, 7 weeks after start of the intervention
Secondary	Central Sensitization Inventory (CSI) POST	Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Central Sensitization Inventory (CSI) FOLLOW-UP	Questionnaire to help identify patients with Central Sensitivity Syndromes. Range 0-100. Five severity levels developed to help aid in the clinical interpretation of the CSI (subclinical = 0-29; mild = 30-39; moderate = 40-49; severe = 50-59; and extreme = 60-100)	52 weeks after start of the intervention
Secondary	Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE	OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	Baseline, 1 week before start of the intervention
Secondary	Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM	OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	Short term, 7 weeks after start of the intervention
Secondary	Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST	OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP	OMPSQ is a self-administered pain screening questionnaire applied to identify patients with acute or subacute musculoskeletal pain who are at risk of delayed recovery. A higher score indicates a higher disability. The maximum score is 210 points; a score of < 105 points indicates a low disability, that between 105 and 130 points indicates a moderate disability and that > 130 points indicates a high disability	52 weeks after start of the intervention
Secondary	Fear Avoidance Components Scale (FACS) PRE	The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.	Baseline, 1 week before start of the intervention
Secondary	Fear Avoidance Components Scale (FACS) SHORT TERM	The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.	Short term, 7 weeks after start of the intervention
Secondary	Fear Avoidance Components Scale (FACS) POST	The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Fear Avoidance Components Scale (FACS) FOLLOW-UP	The FACS scale comprehensively assesses the presence of fear avoidance beliefs and attitudes in people with painful medical conditions. The FACS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which these experiences influence on their activity. There are 20 thoughts or feelings related to avoidance, on 6-point scales with the end points (0) completely disagree and (5) completely agree. The FACS yields a total score between 0, best score, and 100, worst score.	52 weeks after start of the intervention
Secondary	European Quality of Life-5 Dimensions (EQ-5D) PRE	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."	Baseline, 1 week before start of the intervention
Secondary	European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."	Short term, 7 weeks after start of the intervention
Secondary	European Quality of Life-5 Dimensions (EQ-5D) POST	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP	EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. Each dimension is rated in 5 levels from "I have no problem with..." to "I am unable to..."	52 weeks after start of the intervention
Secondary	Lower Limb Functional Index (LLFI) PRE	The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).	Baseline, 1 week before start of the intervention
Secondary	Lower Limb Functional Index (LLFI) POST	The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Lower Limb Functional Index (LLFI) SHORT TERM	The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).	Short term, 7 weeks after start of the intervention
Secondary	Lower Limb Functional Index (LLFI) FOLLOW-UP	The LLFI is an index designed for assessing the functional capacity of the lower limbs with a combination of constructs that includes body functions, body structures, activities and participation, and environmental factors. The LLFI has 25 phrases as items and participants have to select which ones they identify with. The final score is calculated with the following formula: 100 - (number of sentences chosen x 4). The LLFI yields a total score (between 100, best score, and 0, worst score).	52 weeks after start of the intervention
Secondary	Lower limb Strength PRE	Assessment of the isometric strength in the leg press machine using a s-beam load cell	Short term, 7 weeks after start of the intervention
Secondary	Lower limb Strength SHORT TERM	Assessment of the isometric strength in the leg press machine using a s-beam load cell	Short term, 7 weeks after start of the intervention
Secondary	Lower limb Strength POST	Assessment of the isometric strength in the leg press machine using a s-beam load cell	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Lower limb Strength FOLLOW-UP	Assessment of the isometric strength in the leg press machine using a s-beam load cell	52 weeks after start of the intervention
Secondary	Muscular Thickness PRE	Measurement of the muscular thickness (in cm) by Ultrasonography	Baseline, 1 week before start of the intervention
Secondary	Muscular Thickness SHORT TERM	Measurement of the muscular thickness (in cm) by Ultrasonography	Short term, 7 weeks after start of the intervention
Secondary	Muscular Thickness POST	Measurement of the muscular thickness (in cm) by Ultrasonography	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Muscular Thickness FOLLOW-UP	Measurement of the muscular thickness (in cm) by Ultrasonography	52 weeks after start of the intervention
Secondary	Pressure Pain Threshold PRE	Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.	Baseline, 1 week before start of the intervention
Secondary	Pressure Pain Threshold SHORT TERM	Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.	Short term, 7 weeks after start of the intervention
Secondary	Pressure Pain Threshold POST	Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Pressure Pain Threshold FOLLOW-UP	Measurement of the Pressure Pain Threshold of tendon with a hand-held algometer. The tester is placed perpendicular to the skin over the test area, increasing the pressure 30kPa/s. Participants are instructed to indicate when the sensation change from comfortable pressure to slightly unpleasant pain. Test is repeated three times with one minute of rest between repetitions. The mean value is used for the analysis.	52 weeks after start of the intervention
Secondary	Pain at rest measured with Visual Analogue Scale (VAS) PRE	Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	Baseline, 1 week before start of the intervention
Secondary	Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM	Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	Short term, 7 weeks after start of the intervention
Secondary	Pain at rest measured with Visual Analogue Scale (VAS) POST	Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP	Measurement of the Pain at rest with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	52 weeks after start of the intervention
Secondary	Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE	Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	Baseline, 1 week before start of the intervention
Secondary	Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM	Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	Short term, 7 weeks after start of the intervention
Secondary	Pain during activity (running) measured with Visual Analogue Scale (VAS) POST	Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP	Measurement of the Pain during activity (running) with a 100 mm VAS scale, 0 being no pain and 100 being the worst imaginable pain	52 weeks after start of the intervention
Secondary	Treatment satisfaction PRE	Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".	Baseline, 1 week before start of the intervention
Secondary	Treatment satisfaction SHORT-TERM	Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".	Short term, 7 weeks after start of the intervention
Secondary	Treatment satisfaction POST	Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Treatment satisfaction FOLLOW UP	Treatment satisfaction assessed using a visual analog scale, from 0 to 100mm, with 0 being "not at all satisfied" and 10 being "extremely satisfied".	52 weeks after start of the intervention
Secondary	Lower limb Strength measured with hand-held dinamometer PRE	Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.	Baseline, 1 week before start of the intervention
Secondary	Lower limb Strength measured with hand-held dinamometer POST	Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Lower limb Strength measured with hand-held dinamometer SHORT TERM	Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.	Short term, 7 weeks after start of the intervention
Secondary	Lower limb Strength measured with hand-held dinamometer FOLLOW UP	Lower limb Strength measured with hand-held dinamometer (ankle plantarflexion for Achilles tendinopathy, knee extension for patellar tendinopathy, and hip abduction for gluteal tendinopathy). Two repetitions are performed and the mean value is used for the analysis.	52 weeks after start of the intervention
Secondary	HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE	Non invasive surface HDEMG during maximal isometric voluntary contraction performed in a leg press machine. Surface HDEMG is recorded during 20 seconds. Data obtained is analysed to extract the mean discharge rate of the motor units (in fires per second) and the recruitment and derecruitment threshold (in Nw). This variable will only be assessed in a randomly selected subgroup of each arm.	Baseline, 1 week before start of the intervention
Secondary	HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST	Non invasive surface HDEMG during maximal isometric voluntary contraction performed in a leg press machine. Surface HDEMG is recorded during 20 seconds. Data obtained is analysed to extract the mean discharge rate of the motor units (in fires per second) and the recruitment and derecruitment threshold (in Nw). This variable will only be assessed in a randomly selected subgroup of each arm.	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)	Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.	Baseline, 1 week before start of the intervention
Secondary	Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)	Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.	Short term, 7 weeks after start of the intervention
Secondary	Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)	Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.	Post, 14 weeks after start of the intervention (when intervention is finished)
Secondary	Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)	Amount of physical activity of the patients through seven questions about the physical activity performed the previous seven days. Physical activity can be interpreted as a numerical value (reported as median MET-minutes) and as low, moderate, or high activity levels.	52 weeks after start of the intervention