Home-based Exercise in Chronic Kidney Disease (HBCKD-BCN)
Primary Purpose
Chronic Kidney Disease, End-stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home-based exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Exercise, Health-related quality of life, Physical function, Hemodialysis, Peritoneal dialysis
Eligibility Criteria
Inclusion Criteria:
- At least 3 months in hemodialysis treatment
- Clinically stable
Exclusion Criteria:
- Recent cardiac events (less than 3 months)
- Unable to exercise
Sites / Locations
- Hospital de Terrassa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home-based exercise
Arm Description
Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group
Outcomes
Primary Outcome Measures
Change from baseline sit to stand 10 test at 12 and 24 weeks
Sit to stand to sit test 10, time to perform 10 repetitions
Secondary Outcome Measures
Change from baseline Six-minute walking test at 12 and 24 weeks
Distance covered in 6 minutes
Change from baseline STS-60 at 12 and 24 weeks
Sit to stand to sit test 60, number of repetitions performed during 60 seconds
Change from baseline OLHR at 12 and 24 weeks
One leg heel rise test, number of repetitions of heel rise to measure triceps strength
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks
Handgrip strength measured through a dynamometer
Change from baseline SPPB at 12 and 24 weeks
Short physical performance battery, a combination of walking speed, STS-5 and balance
Change from baseline OLST at 12 and 24 weeks
One-leg stand test, time to keep the balance in one leg
Change from baseline TUG at 12 and 24 weeks
Timed up and go test, time to stand up from a chair, walk 3m, turn around and sit back again
Change from baseline Albumin at 12 and 24 weeks
Serum albumin in blood for dialysis patients
Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 24 weeks
Euroquol 5D questionnaire, scale 0 (worst health) to 100 (best health). 5 Dimensions include mobility, personal care, activities of daily living, pain, and anxiety/depression
Change from baseline Beck depression inventory at 12 and 24 weeks
Questionnaire to measure depressive symptoms. Range from 0 (normal) to 63 (worst depression)
Change from baseline Human activity profile at 12 and 24 weeks Human activity profile
Questionnaire to measure physical activity. Higher score represents higher activity. Measures of average and maximal activity scores are reported. Average activity scores bellow 53 are considered impaired; between 53 and 74 are considered moderately active and above 74 are considered active.
Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks
Questionnaire to measure physical activity. Higher scores represent higher activity.
Adherence
Sessions performed/offered x 100
Full Information
NCT ID
NCT03621176
First Posted
July 23, 2018
Last Updated
February 26, 2019
Sponsor
Cardenal Herrera University
Collaborators
Consorci Sanitari de Terrassa. Hospital de Terrassa
1. Study Identification
Unique Protocol Identification Number
NCT03621176
Brief Title
Home-based Exercise in Chronic Kidney Disease
Acronym
HBCKD-BCN
Official Title
Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
Collaborators
Consorci Sanitari de Terrassa. Hospital de Terrassa
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
A home-based exercise program will be implemented in three different groups of participants: advanced chronic kidney disease, end-stage renal disease in substitutive treatment hemodialysis or peritoneal dialysis. Participants will be evaluated before the program, after 3 months and after 6 months from the starting of the program. During the first 3 months the researcher will phone them weekly to reinforce the exercise habit, and during the last three months, there will be no reinforcement. Assessment will include strength, functional capacity, health-related quality of life and depressive symptoms.
Detailed Description
Three groups of participants (advanced chronic disease not yet in substitutive treatment, end-stage renal disease patients in hemodialysis and end-stage renal disease patients in peritoneal dialysis) will enter the study. The intervention will consist of a home-based exercise program. They will be provided with a booklet and the researcher will explain personally each of the exercises to the participants. Progression will be encouraged so that the participants should find the sessions 'somewhat hard' according to the rate of perceived exertion. Reinforcement will be high during the first 3 months (weekly phone calls, visits to the nephrology department) and none during the last 3 months. Assessment will be undertaken at three-time points: baseline, after 3 months of high reinforcement and after 3 more months of no reinforcement at all.
Assessment will include strength, functional capacity, health-related quality of life, cognitive state and depressive symptoms.
The aim of the study is to assess the effectiveness of home-based exercise to improve strength, physical function, health-related quality of life, cognitive state and depressive symptoms in advanced chronic kidney disease and end-stage renal disease (hemodialysis and peritoneal dialysis). We also aim at describing all these variables in the three different groups of patients. Adherence and satisfaction with the exercise program will be recorded at the end of the study.
Additionally, interobserver reliability will be calculated, so as reliability intraobserver in different measurement conditions (dialysis vs non-dialysis days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End-stage Renal Disease
Keywords
Exercise, Health-related quality of life, Physical function, Hemodialysis, Peritoneal dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undertake the exercise intervention. We will compare effects of the intervention between different cohorts included (advanced chronic kidney disease, end-stage renal disease hemodialysis o peritoneal dialysis)
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-based exercise
Arm Type
Experimental
Arm Description
Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group
Intervention Type
Other
Intervention Name(s)
Home-based exercise
Intervention Description
A booklet with detailed information will be provided, and the exercises will be previously reviewed with every patient by the researcher. Participants will be encouraged to perform at least 3 sessions per week and monitor their heart rate. They will be instructed that the exercises should be perceived as 'somewhat hard' from a rate of perceived exertion. Adaptations to increase the intensity of the exercises will be provided so that participants can progress in exercise intensity
Primary Outcome Measure Information:
Title
Change from baseline sit to stand 10 test at 12 and 24 weeks
Description
Sit to stand to sit test 10, time to perform 10 repetitions
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Six-minute walking test at 12 and 24 weeks
Description
Distance covered in 6 minutes
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline STS-60 at 12 and 24 weeks
Description
Sit to stand to sit test 60, number of repetitions performed during 60 seconds
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline OLHR at 12 and 24 weeks
Description
One leg heel rise test, number of repetitions of heel rise to measure triceps strength
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks
Description
Handgrip strength measured through a dynamometer
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline SPPB at 12 and 24 weeks
Description
Short physical performance battery, a combination of walking speed, STS-5 and balance
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline OLST at 12 and 24 weeks
Description
One-leg stand test, time to keep the balance in one leg
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline TUG at 12 and 24 weeks
Description
Timed up and go test, time to stand up from a chair, walk 3m, turn around and sit back again
Time Frame
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Title
Change from baseline Albumin at 12 and 24 weeks
Description
Serum albumin in blood for dialysis patients
Time Frame
Baseline,12 weeks, 24 weeks
Title
Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 24 weeks
Description
Euroquol 5D questionnaire, scale 0 (worst health) to 100 (best health). 5 Dimensions include mobility, personal care, activities of daily living, pain, and anxiety/depression
Time Frame
Baseline,12 weeks, 24 weeks
Title
Change from baseline Beck depression inventory at 12 and 24 weeks
Description
Questionnaire to measure depressive symptoms. Range from 0 (normal) to 63 (worst depression)
Time Frame
Baseline,12 weeks, 24 weeks
Title
Change from baseline Human activity profile at 12 and 24 weeks Human activity profile
Description
Questionnaire to measure physical activity. Higher score represents higher activity. Measures of average and maximal activity scores are reported. Average activity scores bellow 53 are considered impaired; between 53 and 74 are considered moderately active and above 74 are considered active.
Time Frame
Baseline,12 weeks, 24 weeks
Title
Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks
Description
Questionnaire to measure physical activity. Higher scores represent higher activity.
Time Frame
Baseline,12 weeks, 24 weeks
Title
Adherence
Description
Sessions performed/offered x 100
Time Frame
12 weeks, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 3 months in hemodialysis treatment
Clinically stable
Exclusion Criteria:
Recent cardiac events (less than 3 months)
Unable to exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicent Esteve-Simó, PhD
Organizational Affiliation
Hospital de Terrassa
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26306966
Citation
Esteve Simo V, Junque Jimenez A, Moreno Guzman F, Carneiro Oliveira J, Fulquet Nicolas M, Pou Potau M, Saurina Sole A, Duarte Gallego V, Tapia Gonzalez I, Ramirez de Arellano M. Benefits of a low intensity exercise programme during haemodialysis sessions in elderly patients. Nefrologia. 2015;35(4):385-94. doi: 10.1016/j.nefro.2015.03.006. Epub 2015 Jul 21. English, Spanish.
Results Reference
background
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
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Home-based Exercise in Chronic Kidney Disease
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