Patient-Centered Physical Activity Program for Hemodialysis Patients

NCT ID: NCT07080593

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-11-30

Brief Summary

Individuals undergoing HD generally have very low physical activity levels, which consequently contributes to elevated levels of perceptions of fatigue, poor physical function, and a decline in overall quality of life, all of which are linked to progressively greater risk for comorbidities and mortality. The various benefits of physical activity for the general population are well understood, showing a dose-response relationship between physical activity and health. While CKD is not reversible, exercise is often encouraged for its potential to slow disease progression, reduce symptom burden, and improve transplant readiness for HD patients. Over the last two decades, efforts have been made to increase physical activity levels in HD patients, yet the benefits are inconsistent and limited. Many interventions have implemented physical activity programs that include simplistic exercise prescriptions, including intradialytic cycling and/or light resistance exercises. These general, non-personalized exercise programs are associated with poor adherence, high dropout rates, and conflicting effects on physical function or other outcomes related to quality of life. As such, many have discussed the need for individualized exercise prescriptions to overcome the barriers that prevent HD patients from meeting national guidelines for exercise.

In this context, the purpose of this study is to compare the efficacy of a personalized, novel intervention (intervention) compared to a standard of care intervention (comparator), and its effect on perceptions of fatigue, self-reported depression, and physical function. Our primary hypothesis is that the intervention group will elicit greater improvement in physical activity levels than the comparator group. Our secondary hypothesis is that the intervention group will elicit greater improvements in perceptions of fatigue, self-reported depression, and physical function than the comparator group.

Detailed Description

We have designed a novel physical activity intervention that is designed to overcome many of the barriers to increasing physical activity in this population. The novel physical activity program (intervention group) included 2 phases, a structured phase and a self-directed phase. During the structured phase (weeks 0 through 11), the primary goal was to increase physical activity levels. During the self-directed phase (weeks 13 through 24), the primary goal was to encourage continued physical activity by promoting greater participant autonomy.

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 increase the participants' physical activity levels in a sustainable way. Participants had autonomy in selecting their preferred activities, including supervised intradialytic exercises (e.g., cycling or resistance training); at-home exercise (e.g., aerobic, resistance, balance, and flexibility exercises), and lifestyle activities (e.g., gardening, household chores, walking, etc.). 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.

If randomized into the control group, this standard of care group aimed to promote engagement in PA during dialysis treatments, similar to the structure of previous studies. Participants in the comparator group were offered a host of supervised intradialytic exercises, including cycling, and 4 resistance exercises: knee flexion, knee extension, calf raises, and seated marching. Participants were met with during each dialysis treatment (approximately 3 times per week, as scheduling allowed) throughout the entire study period t and support progression were encouraged to progress as tolerated.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Novel Physical Activity Group

The novel PA program included 2 phases, a structured phase and a self-directed phase. During the structured phase, the primary goal was to increase PA levels. Participants had autonomy in selecting their preferred activities, including supervised intradialytic exercises (e.g., cycling or resistance training); at-home exercise (e.g., aerobic, resistance, balance, and flexibility exercises), and lifestyle activities (e.g., gardening, household chores, walking, etc.). Participants were encouraged to progress their PA over time by gradually increasing exercise duration or intensity. During this phase, participants were met with during each dialysis session as scheduling allowed.

During the self-directed phase. the primary goal was to encourage continued PA by promoting greater participant autonomy. Participants determined the frequency of their visits and goal-setting meetings with the research staff, but were met with at least once per week.

Group Type: EXPERIMENTAL

Novel Physical Activity Program

Intervention Type: BEHAVIORAL

A structured phase and a self-directed phase, 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 aligns with the participants' goals and motivations to increase physical activity levels.

Standard of care physical activity group

The standard of care PA program aimed to promote engagement in PA during dialysis treatments, similar to the structure of previous studies14,17,19,20,23. Participants in the comparator group were offered a host of supervised intradialytic exercises, including cycling (Monark information), and 4 resistance exercises: knee flexion, knee extension, calf raises, and seated marching. Participants were met with during each dialysis treatment (approximately 3 times per week, as scheduling allowed) throughout the entire study period to ensure exercises were performed correctly and support progression as appropriate. Participants were encouraged to progress as tolerated. Progression strategies included increasing resistance or exercise duration.

Group Type: ACTIVE_COMPARATOR

Standard of Care Physical Activity Program

Intervention Type: BEHAVIORAL

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

Interventions

Novel Physical Activity Program

A structured phase and a self-directed phase, 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 aligns with the participants' goals and motivations to increase physical activity levels.

Intervention Type: BEHAVIORAL

Standard of Care Physical Activity Program

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

Intervention Type: BEHAVIORAL

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 currently participating in prescribed exercise.
• Physician Clearance: Patients who do not receive physician clearance to participate in the study will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

University of Arizona

OTHER

Sponsor Role: collaborator

Responsible Party

Kenneth Wilund

Director of the School of Nutritional Science and Wellness

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Wilund, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Urbana-Champaign

Locations

US Renal Care

Bolingbrook, Illinois, United States

US Renal Care

Oak Brook, Illinois, United States

Champaign-Urbana Dialysis Center

Urbana, Illinois, United States

Countries

United States

Other Identifiers

21005

Identifier Type: -

Identifier Source: org_study_id