Home-based Exercise in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— HBCKD-BCN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621176
• Other study ID #: HBCKD
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 14, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 3 months in hemodialysis treatment

• Clinically stable

Exclusion Criteria:

• Recent cardiac events (less than 3 months)

• Unable to exercise

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de Terrassa	Terrassa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Cardenal Herrera University	Consorci Sanitari de Terrassa. Hospital de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline Albumin at 12 and 24 weeks	Serum albumin in blood for dialysis patients	Baseline,12 weeks, 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence	Sessions performed/offered x 100	12 weeks, 24 weeks