Home-based vs Intradialysis Exercise Guided by Nursing Staff

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-09

Study Completion Date

2019-11-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease on Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into one of two exercise groups, intradialysis or home-based program

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants

Study Groups

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Intradialysis exercise guided by nursing staff

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

Group Type EXPERIMENTAL

Intradialysis exercise training

Intervention Type OTHER

Combined exercise, aerobic and resistance training, implemented by nursing staff

Home-based exercise program

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.

Group Type ACTIVE_COMPARATOR

Home-based exercise training

Intervention Type OTHER

Combined exercise, aerobic and resistance training, implemented independently home

Interventions

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Intradialysis exercise training

Combined exercise, aerobic and resistance training, implemented by nursing staff

Intervention Type OTHER

Home-based exercise training

Combined exercise, aerobic and resistance training, implemented independently home

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No