Effects of Exercise and Exercise Counselling in Hemodialysis Patients.
|ClinicalTrials.gov Identifier: NCT03334123|
Recruitment Status : Unknown
Verified May 2018 by Jernej Pajek, University Medical Centre Ljubljana.
Recruitment status was: Recruiting
First Posted : November 7, 2017
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity Kidney Diseases Kidney Failure Chronic Kidney Diseases End Stage Renal Disease||Other: Functional training and cycling Other: Cycling||Not Applicable|
Study will include 86 dialysis patients. Investigators will first test the strength of lower limbs with sit-to-stand test, handgrip strength, flexibility, balance, submaximal aerobic capacity, physical characteristics and clinical parameters. After that randomization of patients in two groups will be made - one experimental and one active control group. Patients who will refuse to exercise will be invited to a non-randomized inactive control group (without exercise).
The experimental group will attend 3 times weekly a guided functional exercise before the dialysis procedure for 20 minutes and perform a cycling session during dialysis in the first phase of the study, which will last for 8 weeks. During this time experimental group will receive exercise counselling; instructions how to practice at home will be given by examples and training during functional exercise predialysis sessions.
In the second phase of the study for additional eight weeks participants will be instructed to exercise at home using the skills mastered during the first study phase on non-dialysis days, and continue with the program of intradialysis cycling. Investigators will give them advice, monitor and motivate them.
The active control group will perform intradialytic exercise (intradialysis cycling equal to cycling program of experimental group) during dialysis procedure for four months.
The primary end-point of the study is a change in the 10-repetition sit-to-stand test time as a measure of strength of lower extremities.
Exercise program will be run by a kinesiologist. Main hypothesis is that the guided functional exercise under the surveillance of a kinesiologist added to intradialysis cycling program statistically significantly improves patient's physical performance as compared to the program of intradialysis cycling alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Exercise and Exercise Counselling in Hemodialysis Patients: a Randomized Controlled Trial.|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Functional training and cycling
Participants in this group will perform 20 minutes of functional training before dialysis (in the first 8 weeks) and intradialysis cycling exercise during dialysis. Participants will also receive exercise counselling; investigators will teach them how to practice at home by practice and examples given during the 20 minutes of functional training pre-dialysis. In the second phase of additional eight weeks participants will perform the functional training at home on non-dialysis days in addition to intradialysis cycling. Kinesiologist will monitor, advice and motivate them.
Other: Functional training and cycling
First 8 weeks: patients will perform 20 minutes of functional training before their dialysis procedure. The exercise program will be run by kinesiologists, who will also teach patients how to perform exercises on their own at home. During intradialysis cycling 3 times weekly participants will cycle on adapted ergometer. Participants will start with 10 - 15 minutes of cycling and then gradually increase time and intensity up to 45 minutes of duration.
Second phase of 8 weeks: participants will no longer perform functional training before dialysis but will be motivated, monitored and advised to perform functional exercise at home on non-dialysis days for 20-30 minutes and continue with cycling sessions during the dialysis procedures three times weekly.
Active Comparator: Cycling
This active control comparator group will perform intradialytic cycling on an adapted ergometer 3 times per week for 4 months without functional training prior to dialysis procedure and without exercise counselling.
First 8 weeks: cycling on an adapted ergometer during dialysis; starting with 10 - 15 minutes of cycling and then gradually increasing time and intensity up to 45 minutes of duration.
Second 8 weeks: continue with cycling at the target duration and intensity during dialysis.
- Change in 10 repetition sit-to-stand test time [ Time Frame: baseline, 8 weeks and 16 weeks ]Performance of the sit-to-stand test involves activation of the lower limb muscles; the test measures lower limb strength. Participants are required to 10 times stand up from and sit down on an armless chair as quickly as possible. Their arms should be folded across their chest.
- Change in 6-minute walk test distance [ Time Frame: baseline, 8 weeks and 16 weeks ]Distance made in 6-minute walk test (submaximal aerobic endurance)
- Change in lean and fat body mass [ Time Frame: baseline, 8 weeks and 16 weeks ]Body composition measurements by bioimpedance
- Change in serum interleukin-6 (IL-6) [ Time Frame: baseline, 8 weeks and 16 weeks ]Predialysis serum concentration of IL-6 as a measure of inflammation
- Change in Stork balance test time [ Time Frame: baseline, 8 weeks, 16 weeks ]Stork balance test time as a measure of balance
- Change in sit-and-reach test distance [ Time Frame: baseline, 8 weeks, 16 weeks ]Sit-and-reach test distance as a measure of flexibility
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334123
|Contact: Jernej Pajek, MD, PhDemail@example.com|
|Contact: Špela Bogatajfirstname.lastname@example.org|
|University Medical Centre||Recruiting|
|Contact: Jernej Pajek, PhD|
|Study Chair:||Jadranka Buturović Ponikvar, MD, PhD||UMC Ljubljana|