RECRUITING

Physical Activity Prescription Program for Hemodialysis Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in hemodialysis (HD) patients. Exercise programs often fail to yield robust benefits for many HD patients, in part because the type and volume of exercise prescribed is inappropriate for a variety of reasons, and the benefits from these studies are often disappointing, as they are characterized by poor adherence, high dropout rates, and modest effects on physical function, body composition, cardiovascular disease risk, and other outcomes related to quality of life (QOL). To address this, the investigators have designed a novel physical activity intervention "Move More" that is designed to overcome many of the barriers to increasing physical activity in this population. This study aims to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in HD patients. The investigators primary hypothesis is that patients randomized to the Move More intervention will increase their physical activity levels more than those in the intradialytic exercise group. The main question it aims to answer is: • Does "Move More" increase the physical activity levels (minutes) measured through weekly minutes of physical activity and the LoPAQ questionnaire more than those in the standard intradialytic exercise program? For secondary outcomes this study aims to answer the following: * Does "Move More" improve the physical function of hemodialysis patients assessed by the short physical performance battery (SPBB) more than those in the standard intradialytic exercise program? * Does "Move More" decrease fatigue assess by the SONG-HD survey more than those in the standard intradialytic exercise program? * Does "Move More" decrease symptoms of depression assessed by PROMIS Depression Short Form 8a more than those in the standard intradialytic exercise program? * Does "Move More" increase the amount of exercise measured through a point system more than those in the standard intradialytic exercise program? * Does "Move More" improve blood pressure (BP) more than those in the standard intradialytic exercise program?

Official Title

Development and Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients

Quick Facts

Study Start:2025-02-15
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06830993

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years old (no upper age limit);
  2. * Chronic hemodialysis for ≥ 3 months;
  3. * No planned or expected change in dialysis modality, elective surgery, or relocation during the study period (24 weeks);
  4. * Able to communicate in English or Spanish and provide written informed consent;
  5. * Assessed to be safe and able to exercise by the Hemodialysis unit nephrologist
  1. * Physical Activity: patients undergoing \>150 minutes/week of prescribed PA at baseline will be excluded from the study.
  2. * Physician Clearance: Patients who do not receive physician clearance to participate in the study will be excluded from the study.

Contacts and Locations

Study Contact

Kenneth R Wilud, PhD
CONTACT
520.621.3096
kwilund@arizona.edu
Geovana R Martin Alemany, PhD
CONTACT
520.870.7078
martinalemany@arizona.edu

Principal Investigator

Kenneth R Wilud, PhD
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

DCI Desert Dialysis
Tucson, Arizona, 85719
United States

Collaborators and Investigators

Sponsor: University of Arizona

  • Kenneth R Wilud, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona

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 Registration Dates

Study Start Date2025-02-15
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-02-15
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • hemodialysis
  • physical activity
  • fatigue
  • physical function
  • exercise
  • patient reported outcome

Additional Relevant MeSH Terms

  • Hemodialysis