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HemodialysisMove MoreNCT06830993

Physical Activity Prescription Program for Hemodialysis Patients

A study testing "Move More" Personalized Exercise Program and Intradialytic Exercise Program in people with Hemodialysis, run by University of Arizona at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodialysis
What is being tested?
"Move More" Personalized Exercise Program and Intradialytic Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kenneth R Wilud, PhD contact

520.621.3096

kwilund@arizona.edu

Geovana R Martin Alemany, PhD contact

520.870.7078

martinalemany@arizona.edu

United States1 site, 1 recruiting
  • DCI Desert Dialysis

    Tucson, Arizona, 85719

    Patty Blankenship, RN, (520) 327-0007, patty.blankenship@dciinc.org

    Recruiting

Other trials in United States

About this study

Official title: Development and Testing of an Innovative Patient-Centered Physical Activity Program for Hemodialysis Patients

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.

Read more

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?
Read the 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.

Conditions
Hemodialysis
Being tested
"Move More" Personalized Exercise Program, Intradialytic Exercise Program
Keywords
hemodialysis, physical activity, fatigue, physical function, exercise, patient reported outcome
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.

  • "Move More" Personalized Exercise ProgramBehavioural

    "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 ProgramBehavioural

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

Study groups in NCT06830993
Study groupRoleWhat they receive
Move More Personalized Exercise ProgramExperimentalPersonalized physical activity program aimed to increase the physical activity levels determined through a point system. 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. Weekly challenges/goals will be set to encourage participants to increase their physical activity levels. Participants will have the autonomy to decide about their weekly challenges or goals.
Receives: Behavioral: "Move More" Personalized Exercise Program
Intradialytic Exercise ProgramActive comparatorParticipation in an Intradialytic cycling (exercise during dialysis) physical activity prescription and resistance ("strength training") exercise for 6 months.
Receives: Behavioral: Intradialytic Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical Activity

    Total Minutes of Physical Activity measured with minutes, there is no a minimum or maximin value. If participants increased the total minutes of physical activity this means they increased their physical activity levels.

    Measured: baseline, 3 months, 6 months

Secondary outcomes (5)
  1. Change in Physical Activity

    Low Physical Activity Questionnaire (LoPAQ). Minimum value: 0 (indicating no physical activity). Maximum value: 24 (representing the highest level of low-intensity physical activity measured by the questionnaire)

    Measured: baseline, 3 months, 6 months

  2. Change in Physical Activity

    Points derived from metabolic equivalents (METs). Points of Physical Activity measured with METs, there is not a minimum or maximin value. If participants increased their points this means they increased their physical activity levels. If they decreased their points this means they decrease their physical activity levels.

    Measured: baseline, 3 months, 6 months

  3. Change in Fatigue

    Standardized Outcomes in Nephrology - Hemodialysis Fatigue (SONG-HD Fatigue measure). Minimum Value: 0 (indicating no fatigue). Maximum Value: 10 (indicating the most severe fatigue)

    Measured: baseline, 3 months, 6 months

  4. Change in Depressive symptoms

    Patient Reported Outcomes Measurement Information System- Depression Short Form 8a (PROMIS Depression SF 8a). Minimum Value: 8 (lowest possible raw score, indicating the least depressive symptoms). Maximum Value: 40 (highest possible raw score, indicating the most severe depressive symptoms). The raw scores are typically converted into T-scores (mean = 50, SD = 10) for standardized interpretation.

    Measured: baseline, 3 months, 6 months

  5. Change in Physical function

    Short Physical Performance Battery (SPPB). Minimum Value: 0 (indicating the worst physical performance). Maximum Value: 12 (indicating the best physical performance)

    Measured: baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start1 Jul 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06830993
Sponsor's protocol ID
STUDY00004405
Acronym
Move More
Status last verified
Aug 2025
First submitted
13 Feb 2025
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD used in the results publication

Publications

  • Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.

    PubMed 27909047
  • Koh KP, Fassett RG, Sharman JE, Coombes JS, Williams AD. Effect of intradialytic versus home-based aerobic exercise training on physical function and vascular parameters in hemodialysis patients: a randomized pilot study. Am J Kidney Dis. 2010 Jan;55(1):88-99. doi: 10.1053/j.ajkd.2009.09.025. Epub 2009 Nov 22.

    PubMed 19932545
  • Graham-Brown MPM, March DS, Young R, Highton PJ, Young HML, Churchward DR, Dungey M, Stensel DJ, Bishop NC, Brunskill NJ, Smith AC, McCann GP, McConnachie A, Burton JO. A randomized controlled trial to investigate the effects of intra-dialytic cycling on left ventricular mass. Kidney Int. 2021 Jun;99(6):1478-1486. doi: 10.1016/j.kint.2021.02.027. Epub 2021 Apr 8.

    PubMed 34023029
  • 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.

    PubMed 31200945

Questions about this trial

What is this clinical trial studying?

A study testing "Move More" Personalized Exercise Program and Intradialytic Exercise Program in people with Hemodialysis, run by University of Arizona at 1 site 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kenneth R Wilud, PhD (520.621.3096, kwilund@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Activity (time frame: baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06830993, which also lists 4 linked publications.

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 24 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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