Patient-Centered Physical Activity Program for Hemodialysis Patients

NCT07080593 | Completed

• 1 other identifier: 21005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Hemodialysis

Keywords

Hemodialysis; Physical Activity; Fatigue; Patient Reported Outcomes; Wellness

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity Levels

  MET minutes (physical activity time and intensity) based on the 2011 Compendium of Physical Activities.

  Week 0, week 11, week 23

Secondary Outcomes (3)

• Change in Fatigue

  Week 0, week 11, week 23

• Change in Depressive symptoms

  Week 0, week 11, week 23

• Change in Physical function

  Week 0, week 11, week 23

Study Arms (2)

Novel Physical Activity Group

EXPERIMENTAL

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.

Behavioral: Novel Physical Activity Program

Standard of care physical activity group

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care Physical Activity Program

Interventions

Novel Physical Activity Program 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.

Novel Physical Activity Group

Standard of Care Physical Activity Program BEHAVIORAL

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

Standard of care physical activity group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• University of Arizona: collaborator

Study Sites (3)

US Renal Care

Bolingbrook, Illinois, 60440, United States

Location

US Renal Care

Oak Brook, Illinois, 60515, United States

Location

Champaign-Urbana Dialysis Center

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Wilund, PhD

  University of Illinois Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the School of Nutritional Science and Wellness

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: July 23, 2025
• Study Start: April 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)