NCT06471283

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

June 24, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 29, 2024

Last Update Submit

June 21, 2024

Conditions

Dialysis

Keywords

dialysis patientsphysical activity

Outcome Measures

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.

    17 weeks

Secondary Outcomes (9)

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

    17 weeks

  • Change in muscle parameters

    17 weeks

  • Change in nutritional parameters

    17 weeks

  • Change in inflammatory parameters

    17 weeks

  • Change in lipid profile

    17 weeks

  • +4 more secondary outcomes

Study Arms (1)

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

EXPERIMENTAL

Exercise using the LEMCO Hospital Bed Pedal Exerciser during dialysis.

Other: physical activity

Interventions

physical activityOTHER

Exercising physical activity during dialysis

Also known as: practice of physical activity during dialysis sessions
Single group. This group will practice physical activity during dialysis sessions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHI Andre Gergoire

Montreuil, 93100, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29362960BACKGROUND

  • 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.

    PMID: 29077786BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marion GAUTHIER

    Centre Hospitalier Intercommunal André Grégoire

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Gauthier

CONTACT

01 49 20 30 68marion.gauthier@ght-gpne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 24, 2024

Study Start

March 14, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

June 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)