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RecruitingNCT06471283ACTIDIALUpdated Jun 24, 2024

Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients

An interventional study of physical activity in Dialysis, sponsored by Centre Hospitalier Intercommunal André Grégoire. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Centre Hospitalier Intercommunal André Grégoire · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Dialysis patients have reduced walking capacity and an important risk of high blood pressure. These complications are associated with a decline in quality of life and increased mortality. The hypothesis of the study is to show that physical activity during the dialysis session in dialyzed patients has a benefit on quality of life, as well as on muscle, cardiovascular and dialysis parameters.

Read the detailed description

Dialysis patients have reduced aerobic capacity, walking ability, and an increased risk of hypertension. These complications are associated with a decline in quality of life and increased mortality.

Since asthenia is too intense after the dialysis session, patients are encouraged to perform physical activity during dialysis sessions. Some studies have shown that physical activity during dialysis can have benefits on quality of life and improve muscle parameters, but without this being clinically significant. Other studies show no benefit. The objective of the study is to explore the benefits of physical activity on quality of life, muscle parameters, and biological and dialysis parameters in a cohort of compliant hemodialysis patients.

02

Conditions studied

  • Dialysis

Keywords

  • dialysis patients
  • physical activity
03

In context

Lead sponsor

Centre Hospitalier Intercommunal André Grégoire is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged 18 and over, undergoing chronic hemodialysis at CHI André Grégoire for more than 3 months.
  • Consent to participate in physical activity during dialysis sessions.
  • Written informed consent.
  • Affiliation with a social security system

Exclusion criteria

Exclusion Criteria:

  • Lower limb amputation without a prosthesis.
  • Non-healed foot wounds.
  • Hemoglobin \< 8 g/dl.
  • Patient refusal to participate.
  • Severe respiratory (oxygen dependence) or cardiac disease (NYHA class 3 or 4, LVEF \< 30%).
  • Advanced dementia or psychiatric illness impeding cooperation, or refusal to consent.
  • Non-French speaking patients unable to understand the study.
  • Patients under guardianship.
  • Advanced osteoarthritis, recent hip or knee prosthesis (\< 3 months).
  • Hypotension (BP \< 90/40 mmHg) or hypertension (BP > 180/110 mmHg).
  • Fever (temperature >= 38°C).
  • Hypoglycemia (fingerstick glucose \< 0.8 g/l) in diabetic patients.
  • Dyspnea or desaturation in ambient air \< 95%.
  • COVID-19 symptoms within the last 21 days, positive PCR test, unable to pedal.
  • Chest pain or unstable angina.
  • Muscle or joint contraindications to the pedal exerciser as assessed by a physiotherapist
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Single group. This group will practice physical activity during dialysis sessions.

    Exercise using the LEMCO Hospital Bed Pedal Exerciser during dialysis.

    Other: physical activity

Interventions

  • Otherphysical activity

    Exercising physical activity during dialysis

    Also known as: practice of physical activity during dialysis sessions

06

What researchers measure

Primary outcomes

  1. Change in the quality of life of patients

    Score of the Short Form-36 (SF36) questionnaire. The SF36 score varies from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain. A high score reflects a perception of good health, an absence of functional deficit and pain.

    Time frame: 17 weeks

Secondary outcomes

  1. Change in dialysis parameters (KT/V= clearance time/volume)

    measurement of clearance time/volume (KT/V)

    Time frame: 17 weeks

  2. Change in muscle parameters

    Score of the Medical research council scale (MRC)

    Time frame: 17 weeks

  3. Change in nutritional parameters

    Measurement of body mass index (BMI)

    Time frame: 17 weeks

  4. Change in inflammatory parameters

    measurement of CRP

    Time frame: 17 weeks

  5. Change in lipid profile

    Measurement of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

    Time frame: 17 weeks

  6. Change in blood pressure

    Measurement of systolic and diastolic blood pressure

    Time frame: 17 weeks

  7. Change in heart rate

    measurement of pulse

    Time frame: 17 weeks

  8. Change in glycemic control

    Levels of albumin

    Time frame: 17 weeks

  9. Change in glycemic control

    Levels of prealbumin

    Time frame: 17 weeks

07

Study locations

1 of 1 sites recruiting
  • CHI Andre Gergoire
    Montreuil, 93100, France
    Recruiting
08

References and documents

Publications

  • Cho JH, Lee JY, Lee S, Park H, Choi SW, Kim JC. Effect of intradialytic exercise on daily physical activity and sleep quality in maintenance hemodialysis patients. Int Urol Nephrol. 2018 Apr;50(4):745-754. doi: 10.1007/s11255-018-1796-y. Epub 2018 Jan 23. PubMed 29362960 ↗
  • Assimon MM, Wang L, Flythe JE. Intradialytic Hypertension Frequency and Short-Term Clinical Outcomes Among Individuals Receiving Maintenance Hemodialysis. Am J Hypertens. 2018 Feb 9;31(3):329-339. doi: 10.1093/ajh/hpx186. PubMed 29077786 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06471283
Lead sponsor
Centre Hospitalier Intercommunal André Grégoire
Responsible party
Sponsor
First posted
Jun 24, 2024
Start date
Mar 14, 2024
Primary completion
Mar 31, 2025 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jun 24, 2024

Study contacts

Marion Gauthier
Contact
marion.gauthier@ght-gpne.fr
01 49 20 30 68
Marion GAUTHIER
principal investigator · Centre Hospitalier Intercommunal André Grégoire

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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