Home-based Exercise in Chronic Kidney Disease (HBCKD-BCN)

Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; End-stage Renal Disease
• Intervention / Treatment: Other: Home-based exercise

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).

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08227
      • Hospital de Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 3 months in hemodialysis treatment
• Clinically stable

Exclusion Criteria:

• Recent cardiac events (less than 3 months)
• Unable to exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Home-based exercise; Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group

Other: Home-based exercise; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Six-minute walking test at 12 and 24 weeks	Distance covered in 6 minutes	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline STS-60 at 12 and 24 weeks	Sit to stand to sit test 60, number of repetitions performed during 60 seconds	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLHR at 12 and 24 weeks	One leg heel rise test, number of repetitions of heel rise to measure triceps strength	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks	Handgrip strength measured through a dynamometer	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline SPPB at 12 and 24 weeks	Short physical performance battery, a combination of walking speed, STS-5 and balance	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLST at 12 and 24 weeks	One-leg stand test, time to keep the balance in one leg	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
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	Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Albumin at 12 and 24 weeks	Serum albumin in blood for dialysis patients	Baseline,12 weeks, 24 weeks
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	Baseline,12 weeks, 24 weeks
Change from baseline Beck depression inventory at 12 and 24 weeks	Questionnaire to measure depressive symptoms. Range from 0 (normal) to 63 (worst depression)	Baseline,12 weeks, 24 weeks
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.	Baseline,12 weeks, 24 weeks
Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks	Questionnaire to measure physical activity. Higher scores represent higher activity.	Baseline,12 weeks, 24 weeks
Adherence	Sessions performed/offered x 100	12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Collaborators: Consorci Sanitari de Terrassa. Hospital de Terrassa

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): February 14, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Hemodialysis; Health-related quality of life; Peritoneal dialysis; Physical function
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: HBCKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No