Home-based Exercise in Chronic Kidney Disease
HBCKD-BCN
Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2019
CompletedFebruary 27, 2019
February 1, 2019
6 months
July 23, 2018
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Secondary Outcomes (13)
Change from baseline Six-minute walking test at 12 and 24 weeks
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline STS-60 at 12 and 24 weeks
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLHR at 12 and 24 weeks
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline SPPB at 12 and 24 weeks
Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
- +8 more secondary outcomes
Study Arms (1)
Home-based exercise
EXPERIMENTALHome-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group
Interventions
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
Eligibility Criteria
You may qualify if:
- At least 3 months in hemodialysis treatment
- Clinically stable
You may not qualify if:
- Recent cardiac events (less than 3 months)
- Unable to exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Terrassa
Terrassa, Barcelona, 08227, Spain
Related Publications (2)
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.
PMID: 26306966BACKGROUNDSegura-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.
PMID: 21719637BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vicent Esteve-Simó, PhD
Hospital de Terrassa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 23, 2018
First Posted
August 8, 2018
Study Start
August 1, 2018
Primary Completion
January 31, 2019
Study Completion
February 14, 2019
Last Updated
February 27, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share