Impact of Physical Activity on Quality of Life for Chronic Hemodialysis Patients

NCT06150235 | Unknown

• 1 other identifier: 2023_RIPH_010_QDV-HD
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Hemodialysis

Keywords

Quality of life; chronic hemodialysis patients; factors associated; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Health-related quality of life using KDQOL survey

  Day 0

• Physical activity using RICCI GAGNON test

  Day 0

Study Arms (1)

Chronic hemodialysis patients

patients with chronic hemodialysis

Other: Data collection

Interventions

Data collection OTHER

Data collection

Chronic hemodialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with chronic hemodialysis

You may qualify if:

• Hemodialysis
• Major
• Agreeing to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Université de Reims Champagne-Ardenne: lead

Study Sites (2)

Ufr Medecine Urca

Reims, 51100, France

Location

Université de Reims Champagne Ardenne

Reims, 51100, France

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (2)