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

• ClinicalTrials.gov Identifier: NCT03621176
• Recruitment Status: Completed
• First Posted: August 8, 2018
• Last Update Posted: February 27, 2019
• Sponsor: Cardenal Herrera University
• Collaborator: Consorci Sanitari de Terrassa. Hospital de Terrassa
• Information provided by (Responsible Party): Eva Segura Ortí, Cardenal Herrera University

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease; End-stage Renal Disease	Other: Home-based exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 57 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: January 31, 2019
• Actual Study Completion Date: February 14, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline sit to stand 10 test at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   Sit to stand to sit test 10, time to perform 10 repetitions

Secondary Outcome Measures :

1. Change from baseline Six-minute walking test at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   Distance covered in 6 minutes
2. Change from baseline STS-60 at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   Sit to stand to sit test 60, number of repetitions performed during 60 seconds
3. Change from baseline OLHR at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   One leg heel rise test, number of repetitions of heel rise to measure triceps strength
4. Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   Handgrip strength measured through a dynamometer
5. Change from baseline SPPB at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   Short physical performance battery, a combination of walking speed, STS-5 and balance
6. Change from baseline OLST at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   One-leg stand test, time to keep the balance in one leg
7. Change from baseline TUG at 12 and 24 weeks [ Time Frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks ]
   Timed up and go test, time to stand up from a chair, walk 3m, turn around and sit back again
8. Change from baseline Albumin at 12 and 24 weeks [ Time Frame: Baseline,12 weeks, 24 weeks ]
   Serum albumin in blood for dialysis patients
9. Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 24 weeks [ Time Frame: Baseline,12 weeks, 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
10. Change from baseline Beck depression inventory at 12 and 24 weeks [ Time Frame: Baseline,12 weeks, 24 weeks ]
    Questionnaire to measure depressive symptoms. Range from 0 (normal) to 63 (worst depression)
11. Change from baseline Human activity profile at 12 and 24 weeks Human activity profile [ Time Frame: Baseline,12 weeks, 24 weeks ]
    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.
12. Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks [ Time Frame: Baseline,12 weeks, 24 weeks ]
    Questionnaire to measure physical activity. Higher scores represent higher activity.
13. Adherence [ Time Frame: 12 weeks, 24 weeks ]
    Sessions performed/offered x 100

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• At least 3 months in hemodialysis treatment
• Clinically stable

Exclusion Criteria:

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

Contacts and Locations

Locations

Spain

Hospital de Terrassa

Terrassa, Barcelona, Spain, 08227

Sponsors and Collaborators

Cardenal Herrera University

Consorci Sanitari de Terrassa. Hospital de Terrassa

Investigators

• Study Chair: Vicent Esteve-Simó, PhD; Hospital de Terrassa

More Information

Publications:

Esteve Simo V, Junqué Jiménez A, Moreno Guzmán 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-Ortí E, Martínez-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.

• Responsible Party: Eva Segura Ortí, Professor, Cardenal Herrera University
• ClinicalTrials.gov Identifier: NCT03621176
• Other Study ID Numbers: HBCKD
• First Posted: August 8, 2018
• Last Update Posted: February 27, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eva Segura Ortí, Cardenal Herrera University:

Exercise; Health-related quality of life; Physical function; Hemodialysis; Peritoneal dialysis

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency