Chronic Kidney DiseaseHBCKD-BCNNCT03621176
Home-based Exercise in Chronic Kidney Disease
A study testing Home-based exercise in people with Chronic Kidney Disease and End-stage Renal Disease, run by Cardenal Herrera University at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End-stage Renal Disease
- What is being tested?
- Home-based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2018to 14 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 3 months in hemodialysis treatment
- Clinically stable
Who cannot join
- Recent cardiac events (less than 3 months)
- Unable to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease
- Being tested
- Home-based exercise
- Keywords
- Exercise, Health-related quality of life, Physical function, Hemodialysis, Peritoneal dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Home-based exercise | Experimental | Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group Receives: Other: Home-based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Secondary outcomes (13)
Change from baseline Six-minute walking test at 12 and 24 weeks
Distance covered in 6 minutes
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline,12 weeks, 24 weeks
Adherence
Sessions performed/offered x 100
Measured: 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Jan 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Vicent Esteve-Simó, PhD, Study chair, Hospital de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621176
- Sponsor's protocol ID
- HBCKD
- Acronym
- HBCKD-BCN
- Status last verified
- Feb 2019
- First submitted
- 23 Jul 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26306966Segura-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.
PubMed 21719637
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT03621176
- Acronym / sponsor ID
- HBCKD-BCN / HBCKD
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease
- Keywords
- Exercise, Health-related quality of life, Physical function, Hemodialysis, Peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Consorci Sanitari de Terrassa
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Home-based exercise | Experimental | Other: Home-based exerciseHome-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 3 months in hemodialysis treatment
- Clinically stable
Key exclusion criteria (2 listed)
- Recent cardiac events (less than 3 months)
- Unable to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based exerciseA 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 | Other | Home-based exercise |
Primary outcome
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
13 secondary outcomes
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
Change from baseline STS-60 at 12 and 24 weeks
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLHR at 12 and 24 weeks
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline SPPB at 12 and 24 weeks
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline OLST at 12 and 24 weeks
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline TUG at 12 and 24 weeks
Time frame: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Change from baseline Albumin at 12 and 24 weeks
Time frame: 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
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Beck depression inventory at 12 and 24 weeks
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Human activity profile at 12 and 24 weeks Human activity profile
Time frame: Baseline,12 weeks, 24 weeks
Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks
Time frame: Baseline,12 weeks, 24 weeks
Adherence
Time frame: 12 weeks, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Background: PubMed 26306966Esteve 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.
- Background: PubMed 21719637Segura-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicent Esteve-Simó, PhD study chair
Hospital de Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based exercise in people with Chronic Kidney Disease and End-stage Renal Disease, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621176, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.