End Stage Renal Disease on Dialysis
Conditions
Keywords
Exercise, Hemodialysis
Brief summary
Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking.
Detailed description
During 16 weeks one group will follow an intradialysis exercise program. The exercise program consists of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program includes isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands will be used to apply resistance. Progression will be achieved by increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part of the exercise session will last no more than 30 minutes. The program will also include aerobic exercise (cycling) for up to 30 minutes. Intensity will adapted through the duration of the study so that the participant feel the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance will be adapted progressively. After an initial training period by a physiotherapist, the nursing staff will be responsible for monitoring and implementing the program. The other group will follow a home-based program. A booklet with resistance exercise and recommendation of walking between exercises will be provided. An initial training phase will be applied by the physiotherapists from the rehabilitation department.
Interventions
OTHERIntradialysis exercise training
Combined exercise, aerobic and resistance training, implemented by nursing staff
Combined exercise, aerobic and resistance training, implemented independently home
Sponsors
Hospital de Manises
Cardenal Herrera University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
Intervention model description
Participants will be randomized into one of two exercise groups, intradialysis or home-based program
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients on hemodialysis medically stable, be able to walk at least a few steps, even if you need walking aids like canes or a walker. Life expectancy greater than 6 months
Exclusion criteria
1. Myocardial infarction in the previous 6 weeks 2. Angina unstable on exercise or at rest 3. Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia. 4. Life expectancy less than 6 months 5. Cognitive impairment 6. Language barriers 7. Illiteracy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline short physical performance battery at 16 weeks | Baseline, 16 weeks | Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score |
| Change from baseline gait speed at 16 weeks | Baseline, 16 weeks | Speed to cover 4 meters, in meters/second |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline 6 minutes walk test at 16 weeks | Baseline, 16 weeks | Number of meters walked in 6 minutes |
| Change from baseline handgrip strength at 16 weeks | Baseline, 16 weeks | Bilateral handgrip strength |
| Change from baseline one-leg heel rise test at 16 weeks | Baseline, 16 weeks | Number of heel rise repetitions achieved |
| Change from baseline one-leg standing test at 16 weeks | Baseline, 16 weeks | Time achieved while standing on one leg |
| Change from baseline sit to stand 10 test at 16 weeks | Baseline, 16 weeks | Time to perform 10 repetitions sit to stand |
| Change from baseline Physical activity level at 16 weeks | Baseline, 16 weeks | Physical activity questionnaires |
| Change from baseline Health related quality of life at 16 weeks | Baseline, 16 weeks | Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life |
| Adherence, as number of sessions performed /number of sessions offered | 16 weeks | Sessions performed/sessions offered |
| Change from baseline timed up and go test at 16 weeks | Baseline, 16 weeks | Time to stand up, walk 3 meters, come back and sit down again |
| Change from baseline sit to stand 60 test at 16 weeks | Baseline, 16 weeks | Sit to stand repetitions performed in 60 seconds |
Countries
Belgium, Greece, Spain, Sweden
Outcome results
None listed