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

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intradialysis exercise training
Home-based exercise training
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease on Dialysis focused on measuring Exercise, Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KU Leuven
  • Aristotle University of Thessaloniki
  • Hospital de Manises
  • Universitat de Valencia
  • Universiat de Valéncia
  • Skane Univeristy Hospital
  • Karolinska Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intradialysis exercise guided by nursing staff

Home-based exercise program

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from baseline short physical performance battery at 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
Speed to cover 4 meters, in meters/second

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2019
Last Updated
January 28, 2021
Sponsor
Cardenal Herrera University
Collaborators
Hospital de Manises
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1. Study Identification

Unique Protocol Identification Number
NCT04051515
Brief Title
Home-based vs Intradialysis Exercise Guided by Nursing Staff
Acronym
HoBIDnurse
Official Title
Home-based vs Intradialysis Exercise Program Guided by Nursing Staff
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Hospital de Manises

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
Exercise, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into one of two exercise groups, intradialysis or home-based program
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intradialysis exercise guided by nursing staff
Arm Type
Experimental
Arm Description
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
Arm Title
Home-based exercise program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intradialysis exercise training
Intervention Description
Combined exercise, aerobic and resistance training, implemented by nursing staff
Intervention Type
Other
Intervention Name(s)
Home-based exercise training
Intervention Description
Combined exercise, aerobic and resistance training, implemented independently home
Primary Outcome Measure Information:
Title
Change from baseline short physical performance battery at 16 weeks
Description
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
Time Frame
Baseline, 16 weeks
Title
Change from baseline gait speed at 16 weeks
Description
Speed to cover 4 meters, in meters/second
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline sit to stand 10 test at 16 weeks
Description
Time to perform 10 repetitions sit to stand
Time Frame
Baseline, 16 weeks
Title
Change from baseline sit to stand 60 test at 16 weeks
Description
Sit to stand repetitions performed in 60 seconds
Time Frame
Baseline, 16 weeks
Title
Change from baseline 6 minutes walk test at 16 weeks
Description
Number of meters walked in 6 minutes
Time Frame
Baseline, 16 weeks
Title
Change from baseline handgrip strength at 16 weeks
Description
Bilateral handgrip strength
Time Frame
Baseline, 16 weeks
Title
Change from baseline one-leg heel rise test at 16 weeks
Description
Number of heel rise repetitions achieved
Time Frame
Baseline, 16 weeks
Title
Change from baseline one-leg standing test at 16 weeks
Description
Time achieved while standing on one leg
Time Frame
Baseline, 16 weeks
Title
Change from baseline timed up and go test at 16 weeks
Description
Time to stand up, walk 3 meters, come back and sit down again
Time Frame
Baseline, 16 weeks
Title
Change from baseline Physical activity level at 16 weeks
Description
Physical activity questionnaires
Time Frame
Baseline, 16 weeks
Title
Change from baseline Health related quality of life at 16 weeks
Description
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
Time Frame
Baseline, 16 weeks
Title
Adherence, as number of sessions performed /number of sessions offered
Description
Sessions performed/sessions offered
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Segura-Ortí, PhD
Organizational Affiliation
Universidad CEU Cardenal Herrera, UCH CEU
Official's Role
Principal Investigator
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Aristotle University of Thessaloniki
City
Thessaloníki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Hospital de Manises
City
Manises
State/Province
Valencia
ZIP/Postal Code
46940
Country
Spain
Facility Name
Universitat de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Universiat de Valéncia
City
Valencia
ZIP/Postal Code
46022
Country
Spain
Facility Name
Skane Univeristy Hospital
City
Lund
Country
Sweden
Facility Name
Karolinska Institute
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21719637
Citation
Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.
Results Reference
background
PubMed Identifier
20701722
Citation
Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
Results Reference
background
PubMed Identifier
20098466
Citation
Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
Results Reference
background
PubMed Identifier
30133445
Citation
Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.
Results Reference
background

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Home-based vs Intradialysis Exercise Guided by Nursing Staff

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