Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients (ACTIDIAL)

June 21, 2024 updated by: Centre Hospitalier Intercommunal André Grégoire

Contribution of Physical Activity Per Dialytic in Chronic Dialysis Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montreuil, France, 93100
        • Recruiting
        • CHI Andre Gergoire
        • Contact:
        • Principal Investigator:
          • Marion GAUTHIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Exercising physical activity during dialysis
Other Names:
  • practice of physical activity during dialysis sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the quality of life of patients
Time Frame: 17 weeks

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.
17 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dialysis parameters (KT/V= clearance time/volume)
Time Frame: 17 weeks
measurement of clearance time/volume (KT/V)
17 weeks
Change in muscle parameters
Time Frame: 17 weeks
Score of the Medical research council scale (MRC)
17 weeks
Change in nutritional parameters
Time Frame: 17 weeks
Measurement of body mass index (BMI)
17 weeks
Change in inflammatory parameters
Time Frame: 17 weeks
measurement of CRP
17 weeks
Change in lipid profile
Time Frame: 17 weeks
Measurement of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
17 weeks
Change in blood pressure
Time Frame: 17 weeks
Measurement of systolic and diastolic blood pressure
17 weeks
Change in heart rate
Time Frame: 17 weeks
measurement of pulse
17 weeks
Change in glycemic control
Time Frame: 17 weeks
Levels of albumin
17 weeks
Change in glycemic control
Time Frame: 17 weeks
Levels of prealbumin
17 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal André Grégoire

Investigators

  • Principal Investigator: Marion GAUTHIER, Centre hospitalier Intercommunal André Grégoire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

May 29, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GHT_CHIM_RIRCM20220613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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