Skip to main content
OpenTrials
Completed

NCT Number: NCT03621176

Home-based Exercise in Chronic Kidney 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Behavior Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 3 months in hemodialysis treatment
  • Clinically stable

Exclusion criteria

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

Treatment and study plan

Home-based exercise

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Collaborators

  • Consorci Sanitari de Terrassa

Registry information

Official study title

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

Acronym: HBCKD-BCN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.