HemodialysisNCT07080593
Patient-Centered Physical Activity Program for Hemodialysis Patients
A study testing Novel Physical Activity Program in people with Hemodialysis, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Novel Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
US Renal Care
Bolingbrook, Illinois, 60440
US Renal Care
Oak Brook, Illinois, 60515
Champaign-Urbana Dialysis Center
Urbana, Illinois, 61801
About this study
Official title: Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients
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.
Read the 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
- Being tested
- Novel Physical Activity Program, Standard of Care Physical Activity Program
- Keywords
- Hemodialysis, Physical Activity, Fatigue, Patient Reported Outcomes, Wellness
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Physical Activity ProgramBehavioural
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 ProgramBehavioural
Those in the control group will undergo a variety of exercises including intradialytic cycling and resistance ("strength training")
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of Care Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity Levels
MET minutes (physical activity time and intensity) based on the 2011 Compendium of Physical Activities.
Measured: Week 0, week 11, week 23
Secondary outcomes (3)
Change in Fatigue
SONG-HD Fatigue measure. Scores range from 0 to 9 with higher scores reflecting greater fatigue.
Measured: Week 0, week 11, week 23
Change in Depressive symptoms
Patient Reported Outcomes Measurement Information System- Depression Short Form 8a
Measured: Week 0, week 11, week 23
Change in Physical function
Short Physical Performance Battery
Measured: Week 0, week 11, week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Apr 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arizona
- Responsible party
- Principal investigator, Kenneth Wilund, University of Arizona
- Investigators
- Kenneth Wilund, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080593
- Sponsor's protocol ID
- 21005
- Status last verified
- Jul 2025
- First submitted
- 21 Apr 2021
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07080593
- Acronym / sponsor ID
- 21005
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Physical Activity, Fatigue, Patient Reported Outcomes, Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- University of Arizona
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel Physical Activity Group | Experimental | Behavioral: Novel Physical Activity ProgramThe 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. |
| Standard of care physical activity group | Active comparator | Behavioral: Standard of Care Physical Activity ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Physical Activity ProgramA 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. | Behavioural | Novel Physical Activity Group |
| Standard of Care Physical Activity ProgramThose in the control group will undergo a variety of exercises including intradialytic cycling and resistance ("strength training") | Behavioural | Standard of care physical activity group |
Primary outcome
Change in Physical Activity Levels
Time frame: Week 0, week 11, week 23
MET minutes (physical activity time and intensity) based on the 2011 Compendium of Physical Activities.
3 secondary outcomes
Change in Fatigue
Time frame: Week 0, week 11, week 23
Change in Depressive symptoms
Time frame: Week 0, week 11, week 23
Change in Physical function
Time frame: Week 0, week 11, week 23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Wilund, PhD principal investigator
University of Illinois Urbana-Champaign
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Physical Activity Program in people with Hemodialysis, run by University of Illinois at Urbana-Champaign at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity Levels (time frame: Week 0, week 11, week 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.