Chronic Kidney DiseasesREHABIMUSNCT04820140
Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis
An observational study of Chronic Kidney Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Lymphatic drainage
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2021to 10 Nov 2021
- Phase
- Observational
- 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
Study population: Patients issued from dialysis units (clinic)
Who may be able to join
- Chronic Kidney Disease patient on dialysis (stage 5D) for more than 3 months
- Age > 18 years old
- Stable clinical condition
- Absence of musculoskeletal disorders
Who cannot join
- Cardiovascular contraindication
- Amputation of lower limb not allowing use of elliptical bike
Trial locations and contacts
1 site in 1 country.
About this study
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Lymphatic drainage
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Muscle mass and strength, Training, Survival
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphatic drainageProcedure or surgery
Lymphatic drainage
| Study group | Role | What they receive |
|---|---|---|
| muscle strengthening program | All patients will be receiving a muscle strengthening program consisting in both a training against resistance and an endurance training by elliptical bike during an observational period of 12 weeks for each treatment. Each training program will be preceded by a 4-week period of lymphatic drainage in order to improve neuromuscular sensitivity. Receives: Procedure: Lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional autonomy (frailty) after training
Change in functional autonomy (frailty) after training
Measured: 4 weeks after inclusion
Change in functional autonomy (frailty) after training
Change in functional autonomy (frailty) after training
Measured: 12 weeks after inclusion
Change in functional autonomy (frailty) after training
Change in functional autonomy (frailty) after training and endurance training by elliptical bike during an observational period (12 weeks per program).
Measured: 16 weeks after inclusion
Change in functional autonomy (frailty) after training
Change in functional autonomy (frailty) after training and endurance training by elliptical bike during an observational period (12 weeks per program).
Measured: 32 weeks after inclusion
Secondary outcomes (7)
Change in risk of falling after training
Change in risk of falling after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Change in muscle strength and mass after training
Change in muscle strength and mass after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Change in endurance after training
Change in endurance after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Change in physical activity after training
Change in physical activity after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Change in quality of dialysis after training
Change in quality of dialysis after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Change in nutritional status after training
Change in nutritional status after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Change in neuromuscular sensitivity after training
Change in neuromuscular sensitivity after training
Measured: 4, 12, 16 and 32 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Apr 2021
- Primary completion1 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Study director, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820140
- Sponsor's protocol ID
- RECHMPL21_0031
- Acronym
- REHABIMUS
- Status last verified
- Nov 2021
- First submitted
- 19 Mar 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT04820140
- Acronym / sponsor ID
- REHABIMUS / RECHMPL21_0031
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Muscle mass and strength, Training, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 29 Mar 2021 (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.
Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| muscle strengthening program | – | Procedure: Lymphatic drainageAll patients will be receiving a muscle strengthening program consisting in both a training against resistance and an endurance training by elliptical bike during an observational period of 12 weeks for each treatment. Each training program will be preceded by a 4-week period of lymphatic drainage in order to improve neuromuscular sensitivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients issued from dialysis units (clinic)
Key inclusion criteria (4 listed)
- Chronic Kidney Disease patient on dialysis (stage 5D) for more than 3 months
- Age > 18 years old
- Stable clinical condition
- Absence of musculoskeletal disorders
Key exclusion criteria (2 listed)
- Cardiovascular contraindication
- Amputation of lower limb not allowing use of elliptical bike
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 |
|---|---|---|
| Lymphatic drainageLymphatic drainage | Procedure or surgery | muscle strengthening program |
Primary outcome
Change in functional autonomy (frailty) after training
Time frame: 4 weeks after inclusion
Change in functional autonomy (frailty) after training
Change in functional autonomy (frailty) after training
Time frame: 12 weeks after inclusion
Change in functional autonomy (frailty) after training
Change in functional autonomy (frailty) after training
Time frame: 16 weeks after inclusion
Change in functional autonomy (frailty) after training and endurance training by elliptical bike during an observational period (12 weeks per program).
Change in functional autonomy (frailty) after training
Time frame: 32 weeks after inclusion
Change in functional autonomy (frailty) after training and endurance training by elliptical bike during an observational period (12 weeks per program).
7 secondary outcomes
Change in risk of falling after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
Change in muscle strength and mass after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
Change in endurance after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
Change in physical activity after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
Change in quality of dialysis after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
Change in nutritional status after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
Change in neuromuscular sensitivity after training
Time frame: 4, 12, 16 and 32 weeks after inclusion
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 15 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Jean-Paul CRISTOL, Prof study director
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University Hospital, Montpellier at 1 site in France.
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 4 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 15 Nov 2021. 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 France. 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 in functional autonomy (frailty) after training (time frame: 4 weeks after inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2021.