Renal Insufficiency, ChronicPHYSALYSNCT02818010
Impact of Physical Activity on Patients With Chronic Kidney Disease Not Receiving Dialysis Followed in the TIRCEL Network. An Exposed / Unexposed Study (PHYSALYS)
An observational study of Renal Insufficiency, Chronic, run by Hospices Civils de Lyon.
Trial summary
PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups: patients exposed to physical activity and unexposed. The main objective of the study is to compare the evolution of glomerular filtration rate at inclusion and 12 months later between patients practicing physical activity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Global Physical Activity Questionnaire
- How many people
- 259 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Oct 2015
- 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: Adult patients ( ≥ 18 years); members of TIRCEL network for over a year and having at least two measures of glomerular filtration rate with an interval of at least 9 to 12 months between the first and the last measurement; in CKD stage 3,4 or 5; not on dialysis and not transplanted, making a visit to their nephrologist; agreeing to be contacted at home for a phone call half an hour; not living in institution and being able to answer a questionnaire.
Who may be able to join
- Members of TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for over a year and having at least two measurements of glomerular filtration rate with an interval of 9 to 12 months between the first and the last measurement
- Patients in stages 3, 4 or 5 of CKD
- No dialysis CKD patients
- Non transplanted CKD patients
- Patients seeing nephrologist
- Patients agreeing to be contacted for a phone call half an hour
Show all 9Show fewer
- Adults patients (> 18 years)
- Patients not living in institution
- Patients being able to answer a questionnaire
Who cannot join
- Patients followed in the TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for less than one year or having less than 2 measurements of glomerular filtration rate with an interval of least 9 months or over 12 months between the first and the last measurement
- Patients in stages 1 or 2 of CKD
- CKD patients receiving dialysis
- Transplanted CKD patients
- Patients not seeing nephrologist
- Patients refusing to be contacted for a phone call half an hour
Show all 9Show fewer
- Patients < 18 years
- Patients living in institution
- Patients unable to answer a questionnaire
About this study
PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups: patients exposed to physical activity and unexposed. The main objective of the study is to compare the evolution of glomerular filtration rate at inclusion and 12 months later between patients practicing physical activity and patients not practicing. If necessary, the renal disease-related complications, which are not influenced by physical activity: (type of kidney disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data, 12 months prior to inclusion, is collected retrospectively. Patients are followed in the trial during 12 months. To evaluate physical activity, patients respond to Global Physical Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months period, the same biological data are collected prospectively.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Global Physical Activity Questionnaire
- Keywords
- physical activity, chronic kidney disease, nephrology, stage 3, stage 4, stage 5
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Physical Activity QuestionnaireOther
The practice of physical activity is measured by the GPAQ 2 questionnaire (Global Physical Activity Questionnaire) developed by the World Health Organization.
| Study group | Role | What they receive |
|---|---|---|
| exposed = patient practicing physical activity | The practice of physical activity is measured by the GPAQ 2 questionnaire (Global Physical Activity Questionnaire)
A patient is defined as practicing physical activity (exposed) when he meets one of the conditions following:
* At least 20 minutes of vigorous-intensity physical activity for at least 3 days per week
* At least 30 minutes of moderate-intensity physical activity or walking daily for at least 5 days per week
* At least 5 days of walking and moderate- or vigorous-intensity physical activity achieving at least 600 MET-minutes per week.
The Metabolic equivalents (MET) is the ratio of metabolic rate during activity physical and metabolic rate at rest. One MET corresponds to the energy spent by a person sitting still and is equivalent to a consumption of 1 kcal / kg / hour. It is estimated that a moderately active person has an energetic cost four times higher, and a very active person eight times higher than the energy cost of a person sitting without move. Receives: Other: Global Physical Activity Questionnaire | |
| unexposed = patient not practicing physical activity | The practice of physical activity is measured by the GPAQ 2 questionnaire(Global Physical Activity Questionnaire)
A patient is defined as unexposed if he does not fulfill any of these conditions :
* At least 20 minutes of vigorous-intensity physical activity for at least 3 days per week
* At least 30 minutes of moderate-intensity physical activity or walking daily for at least 5 days per week
* At least 5 days of walking and moderate- or vigorous-intensity physical activity achieving at least 600 MET-minutes per week.
The Metabolic equivalents (MET) is the ratio of metabolic rate during activity physical and metabolic rate at rest. One MET corresponds to the energy spent by a person sitting still and is equivalent to a consumption of 1 kcal / kg / hour. It is estimated that a moderately active person has an energetic cost four times higher, and a very active person eight times higher than the energy cost of a person sitting without move. Receives: Other: Global Physical Activity Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Glomerular Filtration Rate (GFR)
The Glomerular Filtration Rate (GFR) annual slope between inclusion (M0) and 12 months (M12) after inclusion in exposed and unexposed groups.
Measured: Month 0, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMay 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 259 participants (actual)
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
- NCT02818010
- Sponsor's protocol ID
- D50806
- Acronym
- PHYSALYS
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity on Patients With Chronic Kidney Disease Not Receiving Dialysis Followed in the TIRCEL Network. An Exposed / Unexposed Study (PHYSALYS)
- ClinicalTrials.gov ID
- NCT02818010
- Acronym / sponsor ID
- PHYSALYS / D50806
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- physical activity, chronic kidney disease, nephrology, stage 3, stage 4, stage 5
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups: patients exposed to physical activity and unexposed. The main objective of the study is to compare the evolution of glomerular filtration rate at inclusion and 12 months later between patients practicing physical activity and patients not practicing. If necessary, the renal disease-related complications, which are not influenced by physical activity: (type of kidney disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data, 12 months prior to inclusion, is collected retrospectively. Patients are followed in the trial during 12 months. To evaluate physical activity, patients respond to Global Physical Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months period, the same biological data are collected prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed = patient practicing physical activity | – | Other: Global Physical Activity QuestionnaireThe practice of physical activity is measured by the GPAQ 2 questionnaire (Global Physical Activity Questionnaire) A patient is defined as practicing physical activity (exposed) when he meets one of the conditions following: * At least 20 minutes of vigorous-intensity physical activity for at least 3 days per week * At least 30 minutes of moderate-intensity physical activity or walking daily for at least 5 days per week * At least 5 days of walking and moderate- or vigorous-intensity physical activity achieving at least 600 MET-minutes per week. The Metabolic equivalents (MET) is the ratio of metabolic rate during activity physical and metabolic rate at rest. One MET corresponds to the energy spent by a person sitting still and is equivalent to a consumption of 1 kcal / kg / hour. It is estimated that a moderately active person has an energetic cost four times higher, and a very active person eight times higher than the energy cost of a person sitting without move. |
| unexposed = patient not practicing physical activity | – | Other: Global Physical Activity QuestionnaireThe practice of physical activity is measured by the GPAQ 2 questionnaire(Global Physical Activity Questionnaire) A patient is defined as unexposed if he does not fulfill any of these conditions : * At least 20 minutes of vigorous-intensity physical activity for at least 3 days per week * At least 30 minutes of moderate-intensity physical activity or walking daily for at least 5 days per week * At least 5 days of walking and moderate- or vigorous-intensity physical activity achieving at least 600 MET-minutes per week. The Metabolic equivalents (MET) is the ratio of metabolic rate during activity physical and metabolic rate at rest. One MET corresponds to the energy spent by a person sitting still and is equivalent to a consumption of 1 kcal / kg / hour. It is estimated that a moderately active person has an energetic cost four times higher, and a very active person eight times higher than the energy cost of a person sitting without move. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients ( ≥ 18 years); members of TIRCEL network for over a year and having at least two measures of glomerular filtration rate with an interval of at least 9 to 12 months between the first and the last measurement; in CKD stage 3,4 or 5; not on dialysis and not transplanted, making a visit to their nephrologist; agreeing to be contacted at home for a phone call half an hour; not living in institution and being able to answer a questionnaire.
Key inclusion criteria (9 listed)
- Members of TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for over a year and having at least two measurements of glomerular filtration rate with an interval of 9 to 12 months between the first and the last measurement
- Patients in stages 3, 4 or 5 of CKD
- No dialysis CKD patients
- Non transplanted CKD patients
- Patients seeing nephrologist
Key exclusion criteria (9 listed)
- Patients followed in the TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for less than one year or having less than 2 measurements of glomerular filtration rate with an interval of least 9 months or over 12 months between the first and the last measurement
- Patients in stages 1 or 2 of CKD
- CKD patients receiving dialysis
- Transplanted CKD patients
- Patients not seeing nephrologist
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 |
|---|---|---|
| Global Physical Activity QuestionnaireThe practice of physical activity is measured by the GPAQ 2 questionnaire (Global Physical Activity Questionnaire) developed by the World Health Organization. | Other | exposed = patient practicing physical activity, unexposed = patient not practicing physical activity |
Primary outcome
Change of the Glomerular Filtration Rate (GFR)
Time frame: Month 0, Month 12
The Glomerular Filtration Rate (GFR) annual slope between inclusion (M0) and 12 months (M12) after inclusion in exposed and unexposed groups.
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 Jun 2016.
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, Chronic, run by Hospices Civils de Lyon.
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 9 inclusion and 9 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 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 of the Glomerular Filtration Rate (GFR) (time frame: Month 0, Month 12). 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 29 Jun 2016.