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Completed

NCT Number: NCT04051515

Home-based vs Intradialysis Exercise 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Myocardial infarction in the previous 6 weeks
  • Angina unstable on exercise or at rest
  • 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.
  • Life expectancy less than 6 months
  • Cognitive impairment
  • Language barriers
  • Illiteracy

Treatment and study plan

Intradialysis exercise training

Other

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

Home-based exercise training

Other

Combined exercise, aerobic and resistance training, implemented independently home

Primary outcomes

  1. 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

  2. Change from baseline gait speed at 16 weeks

    Time frame: Baseline, 16 weeks

    Speed to cover 4 meters, in meters/second

Secondary outcomes

  1. Change from baseline sit to stand 10 test at 16 weeks

    Time frame: Baseline, 16 weeks

    Time to perform 10 repetitions sit to stand

  2. Change from baseline sit to stand 60 test at 16 weeks

    Time frame: Baseline, 16 weeks

    Sit to stand repetitions performed in 60 seconds

  3. Change from baseline 6 minutes walk test at 16 weeks

    Time frame: Baseline, 16 weeks

    Number of meters walked in 6 minutes

  4. Change from baseline handgrip strength at 16 weeks

    Time frame: Baseline, 16 weeks

    Bilateral handgrip strength

  5. Change from baseline one-leg heel rise test at 16 weeks

    Time frame: Baseline, 16 weeks

    Number of heel rise repetitions achieved

  6. Change from baseline one-leg standing test at 16 weeks

    Time frame: Baseline, 16 weeks

    Time achieved while standing on one leg

  7. 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

  8. Change from baseline Physical activity level at 16 weeks

    Time frame: Baseline, 16 weeks

    Physical activity questionnaires

  9. 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

  10. Adherence, as number of sessions performed /number of sessions offered

    Time frame: 16 weeks

    Sessions performed/sessions offered

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Collaborators

  • Hospital de Manises

Registry information

Official study title

Home-based vs Intradialysis Exercise Program Guided by Nursing Staff

Acronym: HoBIDnurse

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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