Impact of Physical Activity on Quality of Life for Chronic Hemodialysis Patients (QDV-HD)

Chronic end-stage renal disease has a significant impact on patients' quality of life. In 2005, a study evaluating the quality of life of patients with end-stage chronic kidney disease using the SF-36 and KDQoL questionnaires showed that the proportion of patients with an altered quality of life varied from 20% to 50% in the physical component dimensions and from 12% to 47% in the mental component dimensions. More than 75% of dialysis patients had at least one of the 8 scores below the threshold that defines impaired quality of life. In 2011, the Quavi-REIN study involved 1251 dialysis patients showed a significant reduction of quality of life assessed using the generic SF36 questionnaire compared with the general population, in the physical and mental dimensions.

Moreover, in France, more than one senior citizens aged between 55 and 74 in three does not comply with the World Health Organisation's recommendations on the minimum level of physical activity required per day. A sedentary lifestyle is a major public health problem. It is the 4thrisk factor for mortality after hypertension, smoking and diabetes. This inactivity increases mortality and morbidity rates in humans, and consequently the risk of diseases such as cancer and type 2 diabetes.

Physical activity is recommended for patients with chronic kidney disease. In a survey of 505 nephrologists, 97% thought that physical activity is beneficial for dialysis patients, given that a sedentary lifestyle increases the death rate among dialysis patients. Data from the international DOPPS registry, involving 20,920 patients, showed that patients who engage in physical activity have a better quality of life (physical, psychological and sleep quality components), as assessed by the KDQoL-SF questionnaire.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hemodialysis
• Intervention / Treatment: Other: Data collection

Detailed Description

The main objective is to study factors associated with the quality of life of hemodialysis patients, including physical activity.

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• France
  • Reims, France, 51100
    • Ufr Medecine Urca
  • Reims, France, 51100
    • Université de Reims Champagne Ardenne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with chronic hemodialysis

Description

Inclusion Criteria:

• Hemodialysis
• Major
• Agreeing to participate in the study

Exclusion Criteria:

• On peritoneal dialysis
• On daily dialysis at home
• Minors
• Protected by law (guardianship, curatorship, safeguarding of justice)
• Refusing to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic hemodialysis patients; patients with chronic hemodialysis	Other: Data collection; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life using SF-36 survey	Health-related quality of life will be evaluated by the generic questionnaire "Medical Outcomes Study ShortForm General Health Survey" (SF-36) created in 1992 by Ware and Sherbourne and validated in French by Leplège in 1998 The SF-36 is a questionnaire containing 36 items, covering the four weeks preceding the time when the subject is interviewed, grouped into 8 dimensions. Each question is assessed on a Likert scale, with 3, 5 or 6 possible answer levels. The score for each dimension varies from 0 to 100, the higher the score and the better the quality of life.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life using KDQOL survey	It will be evaluated by the questionnaire to chronic kidney disease proposed to patients will be the KDQOL. It will be used in its simplified version of 24 items, divided into 3 dimensions: symptoms and health problems: 12 items; effects of kidney disease: 8 items; burden of kidney disease: 4 items Each question has 5 to 6 possible answer levels, with ratings on a Likert scale ranging from 1 to 5 (excellent/bad) or 1 to 6 (all the time/never). A score is calculated for each dimension and corresponds to the sum of the scores of the questions constituting the dimension, divided by the number of questions for that dimension (average of the scores of the questions). If the answer to a question is missing, it is not taken into account in the calculation of the dimension score.The score for each dimension varies from 0 to 100, the higher the score and the better the quality of life.	Day 0
Physical activity using RICCI GAGNON test	Physical activity will be evaluated by the RICCI GAGNON test . The RICCI GAGNON test is a questionnaire containing 9 questions. Each question is coded from 1 to 5 giving a score out of 45 points. Interpretation is as follows: under 18: inactive; between 18 and 35: active; over 35: very active.	Day 0

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; Quality of life; factors associated; chronic hemodialysis patients
• Other Study ID Numbers: 2023_RIPH_010_QDV-HD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No