Clinical trial NCT06830993: Physical Activity Prescription Program for Hemodialysis Patients
Official title: Development and Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemodialysis
Keywords: hemodialysis
physical activity
fatigue
physical function
exercise
patient reported outcome
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: Individuals with kidney failure receiving maintenance hemodialysis (HD) have very low physical activity levels and poor physical function, and this contributes to a poor quality of life and premature mortality. To help address this problem, many researchers and clinicians have implemented simplistic physical activity programs that include mandated exercise prescriptions such as cycling during dialysis, light resistance training, or at-home walking programs. But 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 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.

The goal of the program is to accumulate an increasing number of points derived from metabolic equivalent (MET) each week the participant is in the program, indicating that their physical activity levels are increasing throughout. The rationale for this approach is that participants are able to choose activities that are important to them, as opposed to prescribed mandated exercises they may not value or benefit from. 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.

This includes developing strategies to incorporate more "lifestyle" physical activity into patients' lives (e.g., grocery shopping, yardwork, walking a dog, etc.), as well as structured exercises, including body weight exercises, flexibility training, aerobic exercise and/or recreational activities. Importantly, the activities that are prescribed are the types that they are willing and able to do. This contrasts with what is normally done, which is to assign specific types of exercise that they may not be motivated or willing to do. The investigstors recently conducted a pilot and feasibility study using this novel intervention approach in dialysis clinics in East-Central Illinois. Our preliminary results indicate that the approach is feasible to implement, and the participants were able to increase their physical activity levels to a much greater extent than is normally seen when using mandated exercise prescriptions. Qualitative data from this trial also indicated that the patients exposed to our "Move More" intervention enjoyed the program and would be willing to maintain their increased physical activity levels after the trial was over.

In this study, participants will be assessed for eligibility and following baseline testing they will be randomly assigned to one of two groups. Patients will complete a medical history form that will help assess participation eligibility. In addition, a physician clearance form must be signed by the patient's nephrologist to participate in the study. Once declared eligible for the study and cleared by their physician, patients will undergo baseline testing.

The first group (Move More) will participate solely in our personalized physical activity prescription (Move More) program. The physical activity prescription will be individualized based on the participants' needs assessment (consultation) at baseline. Exercise progression will also be made on an individual basis and be determined through a point system (METs). Points are derived from metabolic equivalent (MET) scores and can be accumulated by performing any activity (e.g., "lifestyle" activities, aerobic, and/or resistance exercises) the participants complete.

Accumulated points are based on MET values from the Physical Activity compendium. Points are derived from metabolic equivalent (MET) scores and can be accumulated by performing any activity (e.g., "lifestyle" activities, aerobic, and/or resistance exercises) the participants complete. The participants will accumulate points based on MET values from the Physical Activity compendium, which the investigators will provide. For completing 10 minutes of any activity, the participants will "earn" the number of points corresponding to that activity's published MET values. Points will be based on the actual minutes of each activity performed. For example, the published MET value for brisk walking is 3.5 METS. Based on this, the participants will receive 3.5 points for every 10 minutes of brisk walking. The overall goal is to accumulate more points each week for the duration of the intervention.

If randomized into the control group participants will undergo a variety of exercises including intradialytic cycling and resistance ("strength training") exercise. The Move More and Cycle programs will be conducted for 6 months and participants will be engaged to participate 3x/week, during participants' regularly scheduled hemodialysis treatments.

Our 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. Physical activity levels will be assessed using weekly training logs and physical activity questionnaires at baseline and final testing (at 6 months).

At the beginning and end of the study (0 and 6 months), participants will undergo a few tests to measure their physical function, including their walking speed, their ability to rise from a chair, ("sit to stand test"), and a balance test, these tests are part of the Short Physical Performance Battery. The investigators will also provide them with a series of short questionnaires to measure their self-reported physical activity levels (LoPAQ), depression (PROMIS Depression Short Form 8a), and fatigue (SONG-HG survey). The purpose of these tests is to determine if the participants in the "Move-More" group show greater improvements in these measurements than those in the intradialytic exercise group.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old (no upper age limit);
* Chronic hemodialysis for ≥ 3 months;
* No planned or expected change in dialysis modality, elective surgery, or relocation during the study period (24 weeks);
* Able to communicate in English or Spanish and provide written informed consent;
* Assessed to be safe and able to exercise by the Hemodialysis unit nephrologist

Exclusion Criteria:

* Physical Activity: patients undergoing \>150 minutes/week of prescribed PA at baseline will be excluded from the study.
* Physician Clearance: Patients who do not receive physician clearance to participate in the study will be excluded from the study.

Primary outcomes:
measure: Change in Physical Activity
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in Physical Activity
timeFrame: baseline, 3 months, 6 months
measure: Change in Physical Activity
timeFrame: baseline, 3 months, 6 months
measure: Change in Fatigue
timeFrame: baseline, 3 months, 6 months
measure: Change in Depressive symptoms
timeFrame: baseline, 3 months, 6 months
measure: Change in Physical function
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: DCI Desert Dialysis
state: Arizona
Study officials:
affiliation: University of Arizona
name: Kenneth R Wilud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jeong JH, Biruete A, Tomayko EJ, Wu PT, Fitschen P, Chung HR, Ali M, McAuley E, Fernhall B, Phillips SA, Wilund KR. Results from the randomized controlled IHOPE trial suggest no effects of oral protein supplementation and exercise training on physical function in hemodialysis patients. Kidney Int. 2019 Sep;96(3):777-786. doi: 10.1016/j.kint.2019.03.018. Epub 2019 Apr 2.