Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients

NCT ID: NCT06471283

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Exercise using the LEMCO Hospital Bed Pedal Exerciser during dialysis.

Group Type EXPERIMENTAL

physical activity

Intervention Type OTHER

Exercising physical activity during dialysis

Interventions

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physical activity

Exercising physical activity during dialysis

Intervention Type OTHER

Other Intervention Names

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practice of physical activity during dialysis sessions

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal André Grégoire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marion GAUTHIER

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Intercommunal André Grégoire

Locations

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CHI Andre Gergoire

Montreuil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marion Gauthier

Role: CONTACT

01 49 20 30 68

Facility Contacts

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Marion GAUTHIER

Role: primary

01 49 20 30 68

References

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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.

Reference Type BACKGROUND
PMID: 29362960 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29077786 (View on PubMed)

Other Identifiers

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GHT_CHIM_RIRCM20220613

Identifier Type: -

Identifier Source: org_study_id

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