Home-based vs Intradialysis Exercise Guided by Nursing Staff (HoBIDnurse)

January 28, 2021 updated by: Eva Segura Ortí, Cardenal Herrera University

Home-based vs Intradialysis Exercise Program Guided by Nursing Staff

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven
  • Greece
      • Thessaloníki, Greece, 57001
        • Aristotle University Of Thessaloniki
  • Spain
      • Valencia, Spain, 46010
        • Universitat de València
      • Valencia, Spain, 46022
        • Universiat de Valéncia
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
  • Sweden
      • Lund, Sweden
        • Skane Univeristy Hospital
      • Stockholm, Sweden, 14186
        • Karolinska Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: Intradialysis exercise training
Combined exercise, aerobic and resistance training, implemented by nursing staff
Active Comparator: 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.
Other: Home-based exercise training
Combined exercise, aerobic and resistance training, implemented independently home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline short physical performance battery at 16 weeks
Time Frame: 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
Baseline, 16 weeks
Change from baseline gait speed at 16 weeks
Time Frame: Baseline, 16 weeks
Speed to cover 4 meters, in meters/second
Baseline, 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline sit to stand 10 test at 16 weeks
Time Frame: Baseline, 16 weeks
Time to perform 10 repetitions sit to stand
Baseline, 16 weeks
Change from baseline sit to stand 60 test at 16 weeks
Time Frame: Baseline, 16 weeks
Sit to stand repetitions performed in 60 seconds
Baseline, 16 weeks
Change from baseline 6 minutes walk test at 16 weeks
Time Frame: Baseline, 16 weeks
Number of meters walked in 6 minutes
Baseline, 16 weeks
Change from baseline handgrip strength at 16 weeks
Time Frame: Baseline, 16 weeks
Bilateral handgrip strength
Baseline, 16 weeks
Change from baseline one-leg heel rise test at 16 weeks
Time Frame: Baseline, 16 weeks
Number of heel rise repetitions achieved
Baseline, 16 weeks
Change from baseline one-leg standing test at 16 weeks
Time Frame: Baseline, 16 weeks
Time achieved while standing on one leg
Baseline, 16 weeks
Change from baseline timed up and go test at 16 weeks
Time Frame: Baseline, 16 weeks
Time to stand up, walk 3 meters, come back and sit down again
Baseline, 16 weeks
Change from baseline Physical activity level at 16 weeks
Time Frame: Baseline, 16 weeks
Physical activity questionnaires
Baseline, 16 weeks
Change from baseline Health related quality of life at 16 weeks
Time Frame: 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
Baseline, 16 weeks
Adherence, as number of sessions performed /number of sessions offered
Time Frame: 16 weeks
Sessions performed/sessions offered
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Collaborators

Hospital de Manises

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2019

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

November 29, 2019

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HoBIDnurse

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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