Exercise Therapy for Patients With Muscle Dystrophies

Muscular Dystrophies Clinical Trial

Official title:

Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients With Muscle Dystrophies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05081791
• Other study ID #: HCLINIC - MD - 2021
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Universitat Pompeu Fabra
• Contact: Raquel Sebio, PhD
• Phone: +34679336288
• Email: sebio[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy.
• Age > 18 years old
• Ability to walk independently for 10 or more metres

Exclusion Criteria:

• Inability to understand or read Spanish/Catalan.
• Patients engaging in a similar exercise-based program in the past 12 months
• Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program
• Unstable respiratory, cardiovascular or metabolic disease

Related Conditions & MeSH terms

• Muscular Dystrophies

Intervention

Behavioral:
• Exercise Training
12-week exercise training program including a combination of endurance and resistance training for 45 minutes, twice a week.

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Pompeu Fabra	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go	Time consumed by the patient to raise from a chair, walk 3 meters, turn 180º, walk 3 metres back and sit down on the chair	1 week post-intervention
Secondary	Short Physical Performance Battery	Score in this test is derived from three assessments: balance, gait speed and lower limb muscle performance	1 week post-intervention
Secondary	Upper Body Muscle Strength	Muscle strength of the biceps brachii will be assessed with a hand-held dynamometer	1 week post-intervention
Secondary	Lower Body Muscle Strength	Muscle strength of the quadriceps will be assessed with a hand-held dynamometer	1 week post-intervention
Secondary	Handgrip Strength	Handgrip strength will be assessed with a hydraulic dynamometer.	1 week post-intervention
Secondary	Health-Related Quality of Life	HRQoL will be measured with the Short-Form Health Survey (SF-12). The score of the scale goes from 0 - 100, with higher scores representing better health-related quality of life.	1 week post-intervention
Secondary	Body Weight	Body weight (kg)	1 week post-intervention
Secondary	Body Mass Index	Body weight and height will be combined to report the results on body mass index (kg/m2)	1 week post-intervention
Secondary	Percentage of fat-free mass	Percentage of fat-free mass will be obtained through bio-impedance analysis	1 week post-intervention
Secondary	Percentage of fat mass	Percentage of fat mass will be obtained through bio-impedance analysis	1 week post-intervention
Secondary	Fatigue	Fatigue will be quantified with the Brief Fatigue Inventory. The scale has 9 items with a maximal score of 10 points. Higher scores represent heavier fatigue.	1 week post-intervention
Secondary	Respiratory Muscle Strength	Maximal Inspiratory and Expiratory Muscle Strength will be measured according to international guidelines (ATS/ERS) with a MicroRPM.	1 week post-intervention
Secondary	Physical Activity Levels	Accelerometry-assessment of physical activity will be measured in terms of steps per day and minutes spent in light, moderate and vigorous physical activity	1 week post-intervention