Physical Activity Prescription Program for Hemodialysis Patients

NCT06830993 | Recruiting

• 1 other identifier: STUDY00004405
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Hemodialysis

Keywords

hemodialysis; physical activity; fatigue; physical function; exercise; patient reported outcome

Outcome Measures

Primary Outcomes (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.

  baseline, 3 months, 6 months

Secondary Outcomes (5)

• Change in Physical Activity

  baseline, 3 months, 6 months

• Change in Physical Activity

  baseline, 3 months, 6 months

• Change in Fatigue

  baseline, 3 months, 6 months

• Change in Depressive symptoms

  baseline, 3 months, 6 months

• Change in Physical function

  baseline, 3 months, 6 months

Study Arms (2)

Move More Personalized Exercise Program

EXPERIMENTAL

Personalized 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.

Behavioral: "Move More" Personalized Exercise Program

Intradialytic Exercise Program

ACTIVE COMPARATOR

Participation in an Intradialytic cycling (exercise during dialysis) physical activity prescription and resistance ("strength training") exercise for 6 months.

Behavioral: Intradialytic Exercise Program

Interventions

"Move More" Personalized Exercise Program BEHAVIORAL

"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.

Move More Personalized Exercise Program

Intradialytic Exercise Program BEHAVIORAL

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

Intradialytic Exercise Program

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 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

DCI Desert Dialysis

Tucson, Arizona, 85719, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 27909047 BACKGROUND

• 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.

  PMID: 19932545 BACKGROUND

• 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.

  PMID: 34023029 BACKGROUND

• 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.

  PMID: 31200945 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth R Wilud, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth R Wilud, PhD

CONTACT

520.621.3096; kwilund@arizona.edu

Geovana R Martin Alemany, PhD

CONTACT

520.870.7078; martinalemany@arizona.edu

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 and Professor of the School of Nutritional Science and Wellness. University of Arizona

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

US (1)