Chronic Renal FailureNEPHRACTIVENCT04399655
Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients
An observational study of Chronic Renal Failure and Renal Insufficiency, Chronic, run by Clinique Néphrologique Saint-Exupéry at 1 site in France.
Trial summary
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions. Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure, Renal Insufficiency, Chronic
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2020to 4 Jun 2022
- 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: Haemodialysis patient, of full age, for more than 12 months and in front of benefiting/benefiting from a physical activity program
Who may be able to join
- Patient dependent on the CPAM Haute Garonne,
- Patient affiliated to or beneficiary of a French social security scheme,
- Haemodialysis patient for more than 12 months and in front of benefiting/benefiting from a physical activity program,
- Patient age ≥ at 18 years old,
- French speaking patient.
Who cannot join
- Patient with cancer, hepatitis, stage 4 arterial disease, arteritis or amputation of a limb
- Pregnant or breastfeeding women according to article L.1121-5 of the CSP,
- Vulnerable persons according to article L.1121-6 of the CSP,
- Persons of full age under guardianship or curatorship or under safeguard of justice,
- Patient unable to personally give his or her consent, or age of majority protected by law,
- Opposition expressed to inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.
Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.
Read more
Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.
Nevertheless, there are no data on the medico-economic impact of such a program.
Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.
The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in direct and indirect medical costs
Evaluation of medical costs between the 12 months prior to the start of the adapted physical activity program and the 12 months following the start of the adapted physical activity program.
Measured: through study completion, an average of 1 year
Secondary outcomes (11)
change in the quality of life score
Assessed by a The Short Form (36) (SF-36 scale) interpreted by an algorythm
Measured: baseline, at 6 months and at one year
change in body mass index, weight and height will be combined to report BMI in kg/m^2
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in blood presure in mmHg
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in rate of haemoglobin in g/dL
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in percentage of hematocrit and saturation coefficient in %
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in rate of ferritin in ug/L
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in rate of urea, transferrin and blood sugar in g/L
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in rate of potassium in mEq/L
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in rate of bicarbonate in mmol/L
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in rate of calcium, phosphore and C-reactiv protein in mg/L
obtained in start of hemodialysis session
Measured: every month, up to 12 months
change in physical activity evaluation score, from 0 (better) to 20 (worse)
obtained thanks to Borg scale
Measured: baseline, at 6 months and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start12 Nov 2020
- Primary completion4 Jun 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Néphrologique Saint-Exupéry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399655
- Sponsor's protocol ID
- 01/2020
- Other IDs
- 2020-A00209-30
- Acronym
- NEPHRACTIVE
- Status last verified
- Jun 2022
- First submitted
- 11 May 2020
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT04399655
- Acronym / sponsor ID
- NEPHRACTIVE / 01/2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Clinique Néphrologique Saint-ExupéryUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 22 May 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.
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.
Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.
Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.
Nevertheless, there are no data on the medico-economic impact of such a program.
Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.
The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haemodialysis patient, of full age, for more than 12 months and in front of benefiting/benefiting from a physical activity program
Key inclusion criteria (5 listed)
- Patient dependent on the CPAM Haute Garonne,
- Patient affiliated to or beneficiary of a French social security scheme,
- Haemodialysis patient for more than 12 months and in front of benefiting/benefiting from a physical activity program,
- Patient age ≥ at 18 years old,
- French speaking patient.
Key exclusion criteria (6 listed)
- Patient with cancer, hepatitis, stage 4 arterial disease, arteritis or amputation of a limb
- Pregnant or breastfeeding women according to article L.1121-5 of the CSP,
- Vulnerable persons according to article L.1121-6 of the CSP,
- Persons of full age under guardianship or curatorship or under safeguard of justice,
- Patient unable to personally give his or her consent, or age of majority protected by law,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation in direct and indirect medical costs
Time frame: through study completion, an average of 1 year
Evaluation of medical costs between the 12 months prior to the start of the adapted physical activity program and the 12 months following the start of the adapted physical activity program.
11 secondary outcomes
change in the quality of life score
Time frame: baseline, at 6 months and at one year
change in body mass index, weight and height will be combined to report BMI in kg/m^2
Time frame: every month, up to 12 months
change in blood presure in mmHg
Time frame: every month, up to 12 months
change in rate of haemoglobin in g/dL
Time frame: every month, up to 12 months
change in percentage of hematocrit and saturation coefficient in %
Time frame: every month, up to 12 months
change in rate of ferritin in ug/L
Time frame: every month, up to 12 months
change in rate of urea, transferrin and blood sugar in g/L
Time frame: every month, up to 12 months
change in rate of potassium in mEq/L
Time frame: every month, up to 12 months
change in rate of bicarbonate in mmol/L
Time frame: every month, up to 12 months
change in rate of calcium, phosphore and C-reactiv protein in mg/L
Time frame: every month, up to 12 months
change in physical activity evaluation score, from 0 (better) to 20 (worse)
Time frame: baseline, at 6 months and at one year
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 16 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Failure and Renal Insufficiency, Chronic, run by Clinique Néphrologique Saint-Exupéry 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 5 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 16 Nov 2022. 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?
Variation in direct and indirect medical costs (time frame: through study completion, an average of 1 year). 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 16 Nov 2022.