End Stage Renal Disease on DialysisHoBIDnurseNCT04051515
Home-based vs Intradialysis Exercise Guided by Nursing Staff
A study testing Intradialysis exercise training and Home-based exercise training in people with End Stage Renal Disease on Dialysis, run by Cardenal Herrera University at 7 sites in 4 countries.
Trial summary
Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Intradialysis exercise training and Home-based exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 9 Aug 2019to 29 Nov 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
- Patients on hemodialysis medically stable, be able to walk at least a few steps, even if you need walking aids like canes or a walker. Life expectancy greater than 6 months
Who cannot join
- Myocardial infarction in the previous 6 weeks
- Angina unstable on exercise or at rest
- Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
- Life expectancy less than 6 months
- Cognitive impairment
- Language barriers
- Illiteracy
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Spain3 sites
Hospital de Manises
Manises, Valencia, 46940
Universitat de Valencia
Valencia, 46010
Universiat de Valéncia
Valencia, 46022
Sweden2 sites
Skane Univeristy Hospital
Lund
Karolinska Institute
Stockholm, 14186
About this study
Official title: Home-based vs Intradialysis Exercise Program Guided by Nursing Staff
Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking.
Read the detailed description
During 16 weeks one group will follow an intradialysis exercise program. The exercise program consists of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program includes isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands will be used to apply resistance. Progression will be achieved by increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part of the exercise session will last no more than 30 minutes. The program will also include aerobic exercise (cycling) for up to 30 minutes. Intensity will adapted through the duration of the study so that the participant feel the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance will be adapted progressively. After an initial training period by a physiotherapist, the nursing staff will be responsible for monitoring and implementing the program.
The other group will follow a home-based program. A booklet with resistance exercise and recommendation of walking between exercises will be provided. An initial training phase will be applied by the physiotherapists from the rehabilitation department.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Intradialysis exercise training, Home-based exercise training
- Keywords
- Exercise, Hemodialysis
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialysis exercise trainingOther
Combined exercise, aerobic and resistance training, implemented by nursing staff
Home-based exercise trainingOther
Combined exercise, aerobic and resistance training, implemented independently home
| Study group | Role | What they receive |
|---|---|---|
| Intradialysis exercise guided by nursing staff | Experimental | During 16 weeks subjects will exercise during the hemodialysis session, the exercise will include both aerobic and resistance training. Guidance will be provided by nursing staff Receives: Other: Intradialysis exercise training |
| Home-based exercise program | Active comparator | During 16 weeks subjects will exercise on their own at home. A booklet will be provided, with a diary. Instructions to do resistance exercise with intervals of walking will be provided. Initial training will be provided by physiotherapy staff from the hospital. Receives: Other: Home-based exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline short physical performance battery at 16 weeks
Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score
Measured: Baseline, 16 weeks
Change from baseline gait speed at 16 weeks
Speed to cover 4 meters, in meters/second
Measured: Baseline, 16 weeks
Secondary outcomes (10)
Change from baseline sit to stand 10 test at 16 weeks
Time to perform 10 repetitions sit to stand
Measured: Baseline, 16 weeks
Change from baseline sit to stand 60 test at 16 weeks
Sit to stand repetitions performed in 60 seconds
Measured: Baseline, 16 weeks
Change from baseline 6 minutes walk test at 16 weeks
Number of meters walked in 6 minutes
Measured: Baseline, 16 weeks
Change from baseline handgrip strength at 16 weeks
Bilateral handgrip strength
Measured: Baseline, 16 weeks
Change from baseline one-leg heel rise test at 16 weeks
Number of heel rise repetitions achieved
Measured: Baseline, 16 weeks
Change from baseline one-leg standing test at 16 weeks
Time achieved while standing on one leg
Measured: Baseline, 16 weeks
Change from baseline timed up and go test at 16 weeks
Time to stand up, walk 3 meters, come back and sit down again
Measured: Baseline, 16 weeks
Change from baseline Physical activity level at 16 weeks
Physical activity questionnaires
Measured: Baseline, 16 weeks
Change from baseline Health related quality of life at 16 weeks
Medical outcomes survey Short Form 36 questionnaire to measure health-related quality of life, rated from 0 to 100, being the highest score the better the quality of life
Measured: Baseline, 16 weeks
Adherence, as number of sessions performed /number of sessions offered
Sessions performed/sessions offered
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start9 Aug 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of two exercise groups, intradialysis or home-based program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Manises
- Responsible party
- Principal investigator, Eva Segura Ortí, Cardenal Herrera University
- Investigators
- Eva Segura-Ortí, PhD, Principal investigator, Universidad CEU Cardenal Herrera, UCH CEU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051515
- Sponsor's protocol ID
- HoBIDnurse
- Acronym
- HoBIDnurse
- Status last verified
- Jan 2021
- First submitted
- 7 Aug 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21719637Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
PubMed 20701722Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
PubMed 20098466Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.
PubMed 30133445
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based vs Intradialysis Exercise Program Guided by Nursing Staff
- ClinicalTrials.gov ID
- NCT04051515
- Acronym / sponsor ID
- HoBIDnurse / HoBIDnurse
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Exercise, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital de Manises
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 9 Aug 2019 (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.
Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking.
Detailed description
During 16 weeks one group will follow an intradialysis exercise program. The exercise program consists of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program includes isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands will be used to apply resistance. Progression will be achieved by increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part of the exercise session will last no more than 30 minutes. The program will also include aerobic exercise (cycling) for up to 30 minutes. Intensity will adapted through the duration of the study so that the participant feel the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance will be adapted progressively. After an initial training period by a physiotherapist, the nursing staff will be responsible for monitoring and implementing the program.
The other group will follow a home-based program. A booklet with resistance exercise and recommendation of walking between exercises will be provided. An initial training phase will be applied by the physiotherapists from the rehabilitation department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two exercise groups, intradialysis or home-based program
| Arm | Type | Receives |
|---|---|---|
| Intradialysis exercise guided by nursing staff | Experimental | Other: Intradialysis exercise trainingDuring 16 weeks subjects will exercise during the hemodialysis session, the exercise will include both aerobic and resistance training. Guidance will be provided by nursing staff |
| Home-based exercise program | Active comparator | Other: Home-based exercise trainingDuring 16 weeks subjects will exercise on their own at home. A booklet will be provided, with a diary. Instructions to do resistance exercise with intervals of walking will be provided. Initial training will be provided by physiotherapy staff from the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients on hemodialysis medically stable, be able to walk at least a few steps, even if you need walking aids like canes or a walker. Life expectancy greater than 6 months
Key exclusion criteria (7 listed)
- Myocardial infarction in the previous 6 weeks
- Angina unstable on exercise or at rest
- Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
- Life expectancy less than 6 months
- Cognitive impairment
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 |
|---|---|---|
| Intradialysis exercise trainingCombined exercise, aerobic and resistance training, implemented by nursing staff | Other | Intradialysis exercise guided by nursing staff |
| Home-based exercise trainingCombined exercise, aerobic and resistance training, implemented independently home | Other | Home-based exercise program |
Primary outcome
Change from baseline short physical performance battery at 16 weeks
Time frame: Baseline, 16 weeks
Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score
Change from baseline gait speed at 16 weeks
Time frame: Baseline, 16 weeks
Speed to cover 4 meters, in meters/second
10 secondary outcomes
Change from baseline sit to stand 10 test at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline sit to stand 60 test at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline 6 minutes walk test at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline handgrip strength at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline one-leg heel rise test at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline one-leg standing test at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline timed up and go test at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline Physical activity level at 16 weeks
Time frame: Baseline, 16 weeks
Change from baseline Health related quality of life at 16 weeks
Time frame: Baseline, 16 weeks
Adherence, as number of sessions performed /number of sessions offered
Time frame: 16 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 29 Jan 2021.
- 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.
- Background: PubMed 20701722Segura-Orti E, Johansen KL. Exercise in end-stage renal disease. Semin Dial. 2010 Jul-Aug;23(4):422-30. doi: 10.1111/j.1525-139X.2010.00766.x.
- Background: PubMed 20098466Segura-Orti E. [Exercise in haemodyalisis patients: a literature systematic review]. Nefrologia. 2010;30(2):236-46. doi: 10.3265/Nefrologia.pre2010.Jan.10229. Epub 2010 Jan 21. Spanish.
- Background: PubMed 30133445Ortega-Perez de Villar L, Martinez-Olmos FJ, Junque-Jimenez A, Amer-Cuenca JJ, Martinez-Gramage J, Mercer T, Segura-Orti E. Test-retest reliability and minimal detectable change scores for the short physical performance battery, one-legged standing test and timed up and go test in patients undergoing hemodialysis. PLoS One. 2018 Aug 22;13(8):e0201035. doi: 10.1371/journal.pone.0201035. eCollection 2018.
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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.
Eva Segura-Ortí, PhD principal investigator
Universidad CEU Cardenal Herrera, UCH CEU
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialysis exercise training and Home-based exercise training in people with End Stage Renal Disease on Dialysis, run by Cardenal Herrera University at 7 sites in 4 countries.
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 1 inclusion and 7 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Sweden, Belgium, Greece. 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 short physical performance battery at 16 weeks (time frame: Baseline, 16 weeks). The study lists 2 primary outcomes in all. 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 NCT04051515, which also lists 4 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 29 Jan 2021; AzTrials last refreshed its copy on 3 Nov 2026.