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HemodialysisExercise and fitnessBehavioralBehavioral

What this study is

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?

What's being tested

  • "Move More" Personalized Exercise Program

    Intervention · BEHAVIORAL

    "Move More" - a personalized exercise program involving both in center and out-of-center exercise. Our novel intervention provides patient's the autonomy to choose the types of physical activity and exercise that they are willing and able to participate in. In brief, it involves working one-on-one with patients to develop an activity prescription that aims to get participants to "move more", by any means necessary.

  • Intradialytic Exercise Program

    Intervention · BEHAVIORAL

    Those in the intradialytic exercise group will undergo a variety of exercises including intradialytic cycling and resistance ("strength training").

Study details

Official title
Development and Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients
Sponsor
University of Arizona
Conditions
Hemodialysis
Enrolling
40 people
Starts
2025-07-01
Est. completion
2026-10
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗