SarcopeniaIMPREPANCT03671343
Physical Rehabilitation and Chronic Kidney Disease
A study testing Physical rehabilitation in people with Sarcopenia and Chronic Kidney Disease, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia, Chronic Kidney Disease, Older
- What is being tested?
- Physical rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2018to Dec 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- man or woman
- age over 70 years
- CKD stage 3B, 4 or 5 or a DFG <45ml / min according to CKD-EPI formula
- an SPPB (Short Physical Performance Battery test )<10
- having received a complete and loyal information and having given his written and informed consent.
- ability to rehabilitate
Who cannot join
- Subject not presenting previous inclusion criteria
- General condition not compatible for the realization of physical rehabilitation
- Patient protected under the terms of the law.
- Inability to respect the follow-up of the study for geographical, social or psychological reasons.
- depression or other psychiatric disorder
- Refusal to participate in the study
- Absence of affiliation to the social security system
- Subject in a exclusion period of an other study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd
Pierre-Bénite, 69310
Marc BONNEFOY, MD, 0472863704 ext. +33, marc.bonnefoy@chu-lyon.fr
Marc BONNEFOY, MD
Service de Néphrologie, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Laëtitia KOPPE, MD, 0472678715 ext. +33, laetitia.koppe@chu-lyon.fr
Laëtitia KOPPE, MD
About this study
Official title: Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients
Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.
- Conditions
- Sarcopenia, Chronic Kidney Disease, Older
- Being tested
- Physical rehabilitation
- Keywords
- sarcopenia, chronic kidney disease, older
- Medical subject headings
- Sarcopenia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical rehabilitationBehavioural
It will benefit from an initial and final geriatric assessment, an initial dietary balance and a personalized treatment in physical activities adapted for 3 months by an Educator in Adapted Physical Activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention : Physical rehabilitation | Experimental | The Arm "Physical rehabilitation" will benefit from the implementation of the "Loss of Mobility Prevention" program set up in the Department of Aging Medicine of the Center Hospitalier Lyon Sud (CHLS) of Pr BONNEFOY. Receives: Behavioral: Physical rehabilitation |
| Control : optimized medical treatment | No intervention | The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
Measured: Baseline and 3 months
Secondary outcomes (6)
Nutritional parameter: Albuminemia
Measured: Baseline,3 and 6 months
Nutritional parameter: Prealbuminemia
Measured: Baseline,3 and 6 months
Nutritional parameter: Body mass index
Measured: Baseline,3 and 6 months
Nutritional parameter: bioimpedancemetry
Measured: Baseline,3 and 6 months
Muscle strength evaluated by Hand Grip strength test
Measured: Baseline,3 and 6 months
Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)
Measured: Baseline,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study startDec 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671343
- Sponsor's protocol ID
- 69HCL17_0598
- Acronym
- IMPREPA
- Status last verified
- Sep 2018
- First submitted
- 10 Oct 2017
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients
- ClinicalTrials.gov ID
- NCT03671343
- Acronym / sponsor ID
- IMPREPA / 69HCL17_0598
- Conditions
- Sarcopenia, Chronic Kidney Disease, Older
- Keywords
- sarcopenia, chronic kidney disease, older
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Sep 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.
Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention : Physical rehabilitation | Experimental | Behavioral: Physical rehabilitationThe Arm "Physical rehabilitation" will benefit from the implementation of the "Loss of Mobility Prevention" program set up in the Department of Aging Medicine of the Center Hospitalier Lyon Sud (CHLS) of Pr BONNEFOY. |
| Control : optimized medical treatment | No intervention | –The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- man or woman
- age over 70 years
- CKD stage 3B, 4 or 5 or a DFG <45ml / min according to CKD-EPI formula
- an SPPB (Short Physical Performance Battery test )<10
- having received a complete and loyal information and having given his written and informed consent.
Key exclusion criteria (8 listed)
- Subject not presenting previous inclusion criteria
- General condition not compatible for the realization of physical rehabilitation
- Patient protected under the terms of the law.
- Inability to respect the follow-up of the study for geographical, social or psychological reasons.
- depression or other psychiatric disorder
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 |
|---|---|---|
| Physical rehabilitationIt will benefit from an initial and final geriatric assessment, an initial dietary balance and a personalized treatment in physical activities adapted for 3 months by an Educator in Adapted Physical Activities. | Behavioural | Intervention : Physical rehabilitation |
Primary outcome
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
Time frame: Baseline and 3 months
6 secondary outcomes
Nutritional parameter: Albuminemia
Time frame: Baseline,3 and 6 months
Nutritional parameter: Prealbuminemia
Time frame: Baseline,3 and 6 months
Nutritional parameter: Body mass index
Time frame: Baseline,3 and 6 months
Nutritional parameter: bioimpedancemetry
Time frame: Baseline,3 and 6 months
Muscle strength evaluated by Hand Grip strength test
Time frame: Baseline,3 and 6 months
Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)
Time frame: Baseline,3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical rehabilitation in people with Sarcopenia and Chronic Kidney Disease, run by Hospices Civils de Lyon at 2 sites 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laëtitia KOPPE, MD (0472678715 ext. +33, laetitia.koppe@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months (time frame: Baseline and 3 months). 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 14 Sep 2018.