Clinical trial NCT03621176: Home-based Exercise in Chronic Kidney Disease
Official title: Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End-stage Renal Disease
Keywords: Exercise
Health-related quality of life
Physical function
Hemodialysis
Peritoneal dialysis
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Consorci Sanitari de Terrassa. Hospital de Terrassa
First posted: 2018-08-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change from baseline sit to stand 10 test at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Secondary outcomes:
measure: Change from baseline Six-minute walking test at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline STS-60 at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline OLHR at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline SPPB at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline OLST at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline TUG at 12 and 24 weeks
timeFrame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
measure: Change from baseline Albumin at 12 and 24 weeks
timeFrame: Baseline,12 weeks, 24 weeks
measure: Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 24 weeks
timeFrame: Baseline,12 weeks, 24 weeks
measure: Change from baseline Beck depression inventory at 12 and 24 weeks
timeFrame: Baseline,12 weeks, 24 weeks
measure: Change from baseline Human activity profile at 12 and 24 weeks Human activity profile
timeFrame: Baseline,12 weeks, 24 weeks
measure: Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks
timeFrame: Baseline,12 weeks, 24 weeks
measure: Adherence
timeFrame: 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
Study officials:
affiliation: Hospital de Terrassa
name: Vicent Esteve-Simó, PhD
role: STUDY_CHAIR
References:
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.
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.