Home-based vs Intradialysis Exercise Guided by Nursing Staff

Not Applicable

Completed

• Conditions: End Stage Renal Disease on Dialysis
• Interventions: Other: Intradialysis exercise training; Other: Home-based exercise training

• Registration Number: NCT04051515
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study Start: 2019-08-09
• Study First Posted: 2019-08-09
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradialysis exercise guided by nursing staff	Intradialysis exercise training	During 16 weeks subjects will exercise during the hemodialysis session, the exercise will include both aerobic and resistance training. Guidance will be provided by nursing staff
Home-based exercise program	Home-based exercise training	During 16 weeks subjects will exercise on their own at home. A booklet will be provided, with a diary. Instructions to do resistance exercise with intervals of walking will be provided. Initial training will be provided by physiotherapy staff from the hospital.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from baseline sit to stand 60 test at 16 weeks	Baseline, 16 weeks	Sit to stand repetitions performed in 60 seconds
Change from baseline one-leg heel rise test at 16 weeks	Baseline, 16 weeks	Number of heel rise repetitions achieved
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 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 handgrip strength at 16 weeks	Baseline, 16 weeks	Bilateral handgrip strength
Change from baseline one-leg standing test at 16 weeks	Baseline, 16 weeks	Time achieved while standing on one leg
Change from baseline Physical activity level at 16 weeks	Baseline, 16 weeks	Physical activity questionnaires
Adherence, as number of sessions performed /number of sessions offered	16 weeks	Sessions performed/sessions offered
Change from baseline 6 minutes walk test at 16 weeks	Baseline, 16 weeks	Number of meters walked in 6 minutes
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

Trial Locations

Locations (7)

KU Leuven; 🇧🇪 Leuven, Belgium

Hospital de Manises; 🇪🇸 Manises, Valencia, Spain

Universitat de Valencia; 🇪🇸 Valencia, Spain

Universiat de Valéncia; 🇪🇸 Valencia, Spain

Karolinska Institute; 🇸🇪 Stockholm, Sweden

Aristotle University of Thessaloniki; 🇬🇷 Thessaloníki, Greece

Skane Univeristy Hospital; 🇸🇪 Lund, Sweden