Hemodialysis PatientsACTIVDIALNCT01866891
Effects of Physical Activity on the Microcirculation in Hemodialysis Patients
A study testing Three months of regular perdialytic physical activity (cycling) in people with Hemodialysis Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Three months of regular perdialytic physical activity (cycling)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients performing chronic hemodialysis for more than 3 months
- Adult aged > or = 18 years old
- Information letter delivered to subjects
- Written free informed consent
- Clinically stable patients
- Voluntary patients to perform 30 minutes cycling per dialysis session
- Social French Security Affiliated subjects
Who cannot join
- Subjects without inclusion criteria
- Pregnant women
- Subjects protected by the law
- Physical impossibility to achieve exercise
- Medical contraindication to perform physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients
Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.
- Conditions
- Hemodialysis Patients
- Being tested
- Three months of regular perdialytic physical activity (cycling)
- Keywords
- hemodialysis, microcirculation, physical perdialytic activity, cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three months of regular perdialytic physical activity (cycling)Other
Cycling, in lying position, at a rate of thirty minutes per dialysis session (three a week), regardless of performance
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Other: Three months of regular perdialytic physical activity (cycling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of cutaneous lower extremity perfusion.
Measured: TcPO2 will be performed at the inclusion and just after the end of the three month study period
Secondary outcomes (7)
Vascular assessment : Doppler and Index of systolic blood pressure
Measured: At the inclusion and after the end of the three month study period
Related quality of life
Measured: at the inclusion and after the end of the three month study period
Appetite (score)
Measured: at the inclusion and after the end of the three month study period
Daily activity (Seven days pedometers)
Measured: at the inclusion and after the end of the three month study period
Protein intake (n-PCR)
Measured: at the inclusion and after the end of the three month study period
nutritional biological status (creatinin, albumin and transthyretin protein level)
Measured: at the inclusion and after the end of the three month study period
strength (handgrip test)
Measured: at the inclusion and after the end of the three month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startApr 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT01866891
- Sponsor's protocol ID
- 2012.744
- Acronym
- ACTIVDIAL
- Status last verified
- Dec 2025
- First submitted
- 22 May 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pelletier C., Jolivot A., Kalbacher E., Long A., Juillard L. Impact de la pratique d'une activité physique régulière perdialytique sur la microcirculation des membres inférieurs chez les patients hémodialysés chroniques : résultats de l'étude Activdial. Néphrologie & Thérapeutique. 2015;11(5):263. doi:10.1016/j.nephro.2015.07.015.
Panaye, M., Jolivot, A., Lemoine, S., Villar, E., Fouque, D., & Laville, M. (2014). Outcome and prognosis factors of pregnancies in hemodialysis patients. Nephrology Dialysis Transplantation, 29(Suppl 3), iii520. Poster presented at the 51st ERA-EDTA Congress, Amsterdam, Netherlands.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01866891
- Acronym / sponsor ID
- ACTIVDIAL / 2012.744
- Conditions
- Hemodialysis Patients
- Keywords
- hemodialysis, microcirculation, physical perdialytic activity, cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Jun 2013 (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.
Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Other: Three months of regular perdialytic physical activity (cycling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients performing chronic hemodialysis for more than 3 months
- Adult aged > or = 18 years old
- Information letter delivered to subjects
- Written free informed consent
- Clinically stable patients
Key exclusion criteria (5 listed)
- Subjects without inclusion criteria
- Pregnant women
- Subjects protected by the law
- Physical impossibility to achieve exercise
- Medical contraindication to perform physical exercise
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 |
|---|---|---|
| Three months of regular perdialytic physical activity (cycling)Cycling, in lying position, at a rate of thirty minutes per dialysis session (three a week), regardless of performance | Other | single arm |
Primary outcome
Increase of cutaneous lower extremity perfusion.
Time frame: TcPO2 will be performed at the inclusion and just after the end of the three month study period
7 secondary outcomes
Vascular assessment : Doppler and Index of systolic blood pressure
Time frame: At the inclusion and after the end of the three month study period
Related quality of life
Time frame: at the inclusion and after the end of the three month study period
Appetite (score)
Time frame: at the inclusion and after the end of the three month study period
Daily activity (Seven days pedometers)
Time frame: at the inclusion and after the end of the three month study period
Protein intake (n-PCR)
Time frame: at the inclusion and after the end of the three month study period
nutritional biological status (creatinin, albumin and transthyretin protein level)
Time frame: at the inclusion and after the end of the three month study period
strength (handgrip test)
Time frame: at the inclusion and after the end of the three month study period
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 19 Dec 2025.
- Results publicationPelletier C., Jolivot A., Kalbacher E., Long A., Juillard L. Impact de la pratique d'une activité physique régulière perdialytique sur la microcirculation des membres inférieurs chez les patients hémodialysés chroniques : résultats de l'étude Activdial. Néphrologie & Thérapeutique. 2015;11(5):263. doi:10.1016/j.nephro.2015.07.015.
- Results publicationPanaye, M., Jolivot, A., Lemoine, S., Villar, E., Fouque, D., & Laville, M. (2014). Outcome and prognosis factors of pregnancies in hemodialysis patients. Nephrology Dialysis Transplantation, 29(Suppl 3), iii520. Poster presented at the 51st ERA-EDTA Congress, Amsterdam, Netherlands.
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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?
A study testing Three months of regular perdialytic physical activity (cycling) in people with Hemodialysis Patients, run by Hospices Civils de Lyon 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 7 inclusion and 5 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 19 Dec 2025. 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?
Increase of cutaneous lower extremity perfusion. (time frame: TcPO2 will be performed at the inclusion and just after the end of the three month study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01866891, which also lists 2 linked publications.
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 19 Dec 2025.