Late-initiated Blood Flow Restricted Rehabilitation Exercises After Total Knee Replacement

Osteoarthritis, Knee Clinical Trial

— EXKnee2  

Official title:

The Effectiveness of Late-initiated Blood Flow Restricted Rehabilitation Exercises on Functional Capacity, Lower Limb Muscle Strength and Patient-reported Outcomes After Total Knee Replacement

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05770934
• Other study ID #: EXKnee late phase
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: August 30, 2024

Study information

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

Clinical Trial Summary

This trial will investigate the effectiveness of applying low-load blood flow restricted exercise 12 months after receiving a total knee replacement to achieve a functional capacity-level similar to healthy peers. Participants will be allocated to either an exercise group performing a sit-to-stand exercise 4/weekly with concurrent partial restriction of the blood flow to the limbs or a usual care.

Description:

Blood flow restricted exercise (BFRE) is resistance training with low loads (30% 1repetition maximum (RM) performed with concurrent partial blood flow restriction by means of pneumatic cuff compression around the working limb. Group 1: BFRE group: After being introduced to the exercise principles, the participants will perform 4/weekly home-based BFRE sessions for 12 weeks from. Each session will consist of a sit-to-stand exercise performed with concurrent partial restriction of the blood flow to the limbs. The exercise consist of 4 rounds interspaced by 30 seconds of rest. 1st round: 30 repetitions (reps); 2nd round: 15 reps; 3rd round: 15 reps; 4th round: until exhaustion. Patients will rest in a standardized resting position between each set to maintain the desired resting cuff-pressure. The occlusion pressure will be set at 60% of total limb occlusion pressure and starting load intensity will be 30% 1repetition maximum (1RM) in both exercises. If patients can perform more than 15 repetitions in the 4th exercise set, more external resistance will added at the next session. Group 2: CON group: Will follow standard procedures 12 months after total knee replacement. The trial is designed as a multicenter (two sites) randomized controlled trial. The primary outcome, Timed Up and Go, as well as all secondary outcomes measured at end of intervention. The patients in the present project will be recruited from the patients in Jorgensen et al. (1) who have either performed 8 weeks of preoperative BFRE (PREBFR), received usual care prior to total knee replacement (TKR) (PRECON), or participated in the cohort-study. Further, exclusion criteria will remain the same as in Jorgensen et al. (1). before, enrollment all patients will be re-screened for eligibility by the principal author (SLJ) who will perform the inclusion of patients and provide oral and written project information. All patients accepting to participate will sign a written informed consent to participate in the project. All patients who have participated in the randomized controlled trial will be offered 12 weeks of home based BFRE, while all subject who have participated in the cohort-study will be invited to serve as a control group Patients in the home based BFRE group will be carefully instructed in how to perform the BFRE exercises at home. The aim of the current study is to investigate the effectiveness of 12 weeks of BFRE homed-based exercises initiated 12 months after TKR. Furthermore, we will determine if patients who have performed 8 weeks of preoperative BFRE profits more from the late initiated BFRE program compared to patients who have not received 8 weeks of preoperative BFRE. All descriptive statistics and tests will be reported in accordance with the recommendations of the "Enhancing the QUAlity and Transparency Of health Research" (EQUATOR) network and the CONSORT statement. Intention-to-treat principle (i.e. all patients as randomized independent of departures from allocation treatment, compliance and/or withdrawals) and per protocol analysis will be conducted. A one-way analysis of variance (one-way ANOVA) model will be used to analyze between mean change in continuous outcome measures between the group of patients who have performed 8 weeks of preoperative BFRE (PREBFR) and the group who did not perform 8 weeks of preoperative BFRE (PRECON) (27). The model includes changes from baseline to end of intervention. Also, to gain insight into the potential pre-to-post training differences within the whole patient population (PREBFR+PROCON), the PREBFR-patients and the PRECON-participants, paired student t-tests will be performed. Level of statistical significance is P < 0.05.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 56
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients included in the EXknee project (Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee) Jorgensen et al. 2020)

Exclusion Criteria:

• Severe cardiovascular diseases (New York Heart Association class III and IIII), -
• previous stroke incident, thrombosis incident
• Traumatic nerve injury in affected limb
• Unregulated hypertension (Systolic =180 or diastolic =110 mmHg)
• Spinal cord injury
• Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
• Inadequacy in written and spoken Danish
• living more than 45 minutes from either Horsens Regional Hospital or Silkeborg Regional Hospital.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Osteoarthritis, Knee

Intervention

Other:
• Blood flow restricted low-load resistance exercise
Blood flow restricted low-load resistance exercise

Locations

Country	Name	City	State
Denmark	Regional Hospital Horsens	Horsens

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Horsens Hospital, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-seconds chair stand test (30-CST)	The 30s-CST measures the number of sit-to-stand repetitions completed within 30 seconds. Patients will be instructed to perform a sit-to-stand movement starting from a seated position (seat height 43 cm without armrests) having the feet placed flat on the floor shoulder width apart, and arms crossed on chest to a standing position (hip and knee joints fully extended) repeated as many times as possible for 30 seconds	1 year after surgery
Primary	Change in 30-seconds chair stand test (30-CST)	The 30s-CST measures the number of sit-to-stand repetitions completed within 30 seconds. Patients will be instructed to perform a sit-to-stand movement starting from a seated position (seat height 43 cm without armrests) having the feet placed flat on the floor shoulder width apart, and arms crossed on chest to a standing position (hip and knee joints fully extended) repeated as many times as possible for 30 seconds	15 months after surgery
Secondary	Timed Up & Go (TUG)	The TUG assesses the time required for patients to stand from a chair (seat height 46 cm) walk around a tape mark 3 meters away and sit into the chair at return.	1 yeay after surgery
Secondary	Timed Up & Go (TUG)	The TUG assesses the time required for patients to stand from a chair (seat height 46 cm) walk around a tape mark 3 meters away and sit into the chair at return.	15 months after surgery
Secondary	4x10 meter fast-paced walk test (40m-FWT)	The 40m fast-paced walk test (40m-FWT) measures the total time taken to walk 4 x 10 m excluding turns (meter/sec).	1 year after surgery
Secondary	4x10 meter fast-paced walk test (40m-FWT)	The 40m fast-paced walk test (40m-FWT) measures the total time taken to walk 4 x 10 m excluding turns (meter/sec).	15 months after surgery
Secondary	Isometric knee extensor strength	Isometric knee extensor muscle strength will be measured with the participants seated on a examination table with knees and hip positioned at 90 degree flexion. Assessment of muscle strength will be performed with a hand-held dynamometer, fixed with an adjustable rigid belt to the examination table.	1 year after surgery
Secondary	Isometric knee extensor strength	Isometric knee extensor muscle strength will be measured with the participants seated on a examination table with knees and hip positioned at 90 degree flexion. Assessment of muscle strength will be performed with a hand-held dynamometer, fixed with an adjustable rigid belt to the examination table.	15 months after surgery
Secondary	Isometric knee flexor strength	Isometric knee flexor muscle strength will be measured with the participants seated on a examination table with knees and hip positioned at 90 degree flexion. Assessment of muscle strength will be performed with a hand-held dynamometer, fixed with an adjustable rigid belt to the examination table	1 year after surgerty
Secondary	Isometric knee flexor strength	Isometric knee flexor muscle strength will be measured with the participants seated on a examination table with knees and hip positioned at 90 degree flexion. Assessment of muscle strength will be performed with a hand-held dynamometer, fixed with an adjustable rigid belt to the examination table	15 months after surgery
Secondary	Knee disability and Osteoarthritis Outcome Score (KOOS)	KOOS is a patient-administered knee specific questionnaire comprising five subscales Pain; Symptoms; Activities of daily living; Sport & Recreation; and Knee-Related Quality of Life.	1 year after surgery
Secondary	Knee disability and Osteoarthritis Outcome Score (KOOS)	KOOS is a patient-administered knee specific questionnaire comprising five subscales Pain; Symptoms; Activities of daily living; Sport & Recreation; and Knee-Related Quality of Life.	15 months after surgery
Secondary	EuroQol Group 5-dimension (EQ-5D-5L)after surgery	The EQ-5D-L5 is a self-completion questionnaire consisting of two parts; first part of the EQ-5D-5L comprises five dimensions involving mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	1 year after surgery
Secondary	EuroQol Group 5-dimension (EQ-5D-5L)after surgery	The EQ-5D-L5 is a self-completion questionnaire consisting of two parts; first part of the EQ-5D-5L comprises five dimensions involving mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	15 months after surgery
Secondary	Adverse events	Adverse events will be defined as unpredicted or unintended events, signs, or disease occurring during the period from inclusion until follow-up resulting in contact with the healthcare system (hospital or general practitioner) independent of whether or not the event is related to the intervention or outcome assessments	15 months after surgery
Secondary	Exercise compliance and progression	The participants will report their adherence, experience and understanding of the training in a training diary	15 months after surgery
Secondary	Numeric Rating Scale Pain (NRS pain)	The NRS for pain is a segmented unidimensional 11-item measure of pain intensity in adults	1 year after surgery
Secondary	Numeric Rating Scale Pain (NRS pain)	The NRS for pain is a segmented unidimensional 11-item measure of pain intensity in adults	15 months after surgery
Secondary	Numeric Rating Scale Pain (NRS pain)	The NRS for pain is a segmented unidimensional 11-item measure of pain intensity in adults	during 12 weeks exercise program