Inactivity and Quality of Life in Dialysis Patients

March 24, 2023 updated by: Pardis Specialized Wellness Institute

Inactivity and Health Related Quality of Life in Dialysis Patients and Peritoneal Dialysis Patients

The goal of this observational study is to compare hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:

  • What is the level of physical activity in hemodialysis and peritoneal dialysis patients?
  • What is the level of quality of life of hemodialysis and peritoneal dialysis patients?
  • Is there any relation between inactivity and quality of life in hemodialysis and peritoneal dialysis patients?

Participants will answer 2 questionnaires and will do some functional tests.

Study Overview

Status

Completed

Conditions

Detailed Description

Physical functioning and physical activity are low in patients treated with maintenance hemodialysis (HD).

One of the factors that lead to a further decrease in the activity of hemodialysis patients and its complications is the immobility of these patients during hemodialysis. This method of treatment forces patients to remain motionless for 4 hours on average 3 times a week. In addition, fatigue after dialysis also requires additional rest and immobility for about 2 to 6 hours.

Sedentary behaviors are also common in peritoneal dialysis (PD) patients (about 63%), and studies have shown that there is no significant difference between the physical activity level of PD and HD patients.

In PD patients, in addition to reducing functional capacity and feeling extreme fatigue, the fear of dialysis fluid leakage, hernia and infection also causes a decrease in physical activity and an increase in inactivity in these patients.

The lack of physical mobility and the resulting movement restrictions affect the patient's independence and ability to perform daily tasks, including self-care. In addition, the emotional and mental health of patients is greatly affected by these restrictions Inactivity sets off a vicious cycle in which energy imbalances can increase comorbidities such as hypertension, diabetes, coronary artery disease, depressive disorders, hospitalization rates, and disability. Each of these conditions aggravates the decrease in the quality of life and increases the mortality of patients.

Quality of life is an important aspect of treatment outcomes and should be considered when evaluating the quality and effectiveness of renal care services.

The quality of life in CKD patients and especially dialysis patients decreases under the influence of several factors such as weakness, disability, reduced functional capacity, anemia, malnutrition, impaired cognitive function, worsening sleep quality, increased depression, and the development of cardiovascular disorders The quality of life of renal patients and its social and emotional aspects are considered as the main determinants of these clinical outcomes.

Decreasing the quality of life in hemodialysis patients and peritoneal dialysis patients decreases the survival and increases the mortality of these patients. Improving the quality of life should not only be considered as a therapeutic goal in itself, but should also be considered as an essential factor in reducing the number of hospitalizations and deaths of dialysis patients.

This study aims to evaluate the quality of life of HD patients as well as PD patients. Also this study will evaluate the effect of inactivity on quality of life, stratified by both dialysis modality and will compere the results in these two dialysis modalities.

Study Type

Observational

Enrollment (Actual)

120

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

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

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hemodialysis and peritoneal dialysis patients being treated with the same respective dialysis modalities for at least 3 months and being ambulatory (with or without assistive device) will be included.

But non-ambulatory patients having significant cognitive dysfunction, progressive degenerative,neurologic disease or severe rheumatologic or orthopedic conditions, angina upon exertion, or myocardial infarction or cardiac surgery within the last year will be excluded.

Description

Inclusion Criteria:

  • being treated with the same respective dialysis modalities for at least 3 months
  • being ambulatory (with or without assistive device)
  • ability to understand and provide informed consent

Exclusion Criteria:

  • non-ambulatory
  • had significant cognitive dysfunction
  • progressive degenerative
  • neurologic disease
  • severe rheumatologic or orthopedic conditions that would limit and would be exacerbated by the testing
  • angina upon exertion, or myocardial infarction or cardiac surgery within the last year.

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

Cohorts and Interventions

Group / Cohort
Hemodialysis patients
They will fill 2 questionnaires and ill do some functional tests.
Peritoneal dialysis patients
They will fill 2 questionnaires and ill do some functional tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life level
Time Frame: Through out study completion, an average of 2 weeks
Quality of life will be assessed by health related quality of life questionnaire for chronic kidney disease patients Higher scores indicate higher levels of quality of life
Through out study completion, an average of 2 weeks
Physical activity level
Time Frame: Through out study completion, an average of 2 weeks
Physical activity level will be assessed by Low Physical activity questionnaire (LoPAQ) This questionnaire assesses the levels of physical activity and will be explained by calories expenditure. Those who are less active will have lower calories expenditure.
Through out study completion, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical functioning level
Time Frame: Through out study completion, an average of 2 weeks

Physical functioning level will be assessed by short physical performance battery test.

The range of this test score is 0-12. Those who have disabilities in the activity of their daily living will take lower scores.
Through out study completion, an average of 2 weeks

Collaborators and Investigators

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

Sponsor

Pardis Specialized Wellness Institute

Investigators

  • Principal Investigator: MohammadAli Tabibi, PhD, Pardis Specialized Wellness Institute

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)

February 28, 2023

Primary Completion (Actual)

March 20, 2023

Study Completion (Actual)

March 22, 2023

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA23ES-1-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.

IPD Sharing Time Frame

The data will be available after the paper is published. No end date.

IPD Sharing Access Criteria

Data will be accessible with no criteria. Anyone who wishes will have access to data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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