Chronic Kidney DiseasesDIALEXNCT04538248
Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients
An observational study of Chronic Kidney Diseases and Hemodialysis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Hemodialysis, Physical Rehabilitation
- What is being tested?
- Combined rehabilitation during hemodialysis
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 1 Mar 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients of Montpellier AIDER Santé dialysis center
Who may be able to join
- Hemodialysis started since at least 3 months
- Medical prescription of perdialytic combined exercise
- Age < 85
- Life expectancy > 6 months
Who cannot join
- Ischemic and valvular cardiopathies
- Lower-extremity arterial disease (stade III and IV)
- Knee or hip amputation/prothesis
- Severe respiratory disease
- BMI > 35
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients: a Comparative Study of Current Practices.
Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an assessment of physical activities and muscle strength in the Montpellier and Nimes centers. In order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical Performance Battery). Recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. In AIDER Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). It is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. Therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.
- Being tested
- Combined rehabilitation during hemodialysis
- Keywords
- Perdialytic exercise, Combined rehabilitation, Functional abilities, Interference effect
- 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.
Combined rehabilitation during hemodialysisOther
Combined rehabilitation during hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Continuous | Continuous Receives: Other: Combined rehabilitation during hemodialysis | |
| Discontinuous | Discontinuous Receives: Other: Combined rehabilitation during hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical
Short Physical Performance Battery Score
Measured: Week 0, week 17
Secondary outcomes (1)
Knee extension force
Knee extension force
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion1 Mar 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Principal investigator, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538248
- Sponsor's protocol ID
- RECHMPL20_0403
- Acronym
- DIALEX
- Status last verified
- Mar 2021
- First submitted
- 2 Sep 2020
- Last updated
- 18 Mar 2021
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients: a Comparative Study of Current Practices.
- ClinicalTrials.gov ID
- NCT04538248
- Acronym / sponsor ID
- DIALEX / RECHMPL20_0403
- Keywords
- Perdialytic exercise, Combined rehabilitation, Functional abilities, Interference effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 Sep 2020 (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.
Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an assessment of physical activities and muscle strength in the Montpellier and Nimes centers. In order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical Performance Battery). Recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. In AIDER Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). It is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. Therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous | – | Other: Combined rehabilitation during hemodialysisContinuous |
| Discontinuous | – | Other: Combined rehabilitation during hemodialysisDiscontinuous |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients of Montpellier AIDER Santé dialysis center
Key inclusion criteria (4 listed)
- Hemodialysis started since at least 3 months
- Medical prescription of perdialytic combined exercise
- Age < 85
- Life expectancy > 6 months
Key exclusion criteria (6 listed)
- Ischemic and valvular cardiopathies
- Lower-extremity arterial disease (stade III and IV)
- Knee or hip amputation/prothesis
- Severe respiratory disease
- BMI > 35
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 |
|---|---|---|
| Combined rehabilitation during hemodialysisCombined rehabilitation during hemodialysis | Other | Continuous, Discontinuous |
Primary outcome
Short Physical
Time frame: Week 0, week 17
Short Physical Performance Battery Score
1 secondary outcome
Knee extension force
Time frame: 1 day
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 18 Mar 2021.
- 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.
Jean-Paul CRISTOL, Prof principal investigator
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 and Hemodialysis, 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 6 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 18 Mar 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?
Short Physical (time frame: Week 0, week 17). 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 18 Mar 2021.