The Effect of Home-Based Tele-Exercise on Dialysis Patients

NCT06313892 | Completed DMC

• 1 other identifier: PA24HD-2-05
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele-exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy.

Conditions

End Stage Renal Disease; Hemodialysis Complication

Keywords

Inactivity; Tele-exercise; Home-based exercise; Hemodialysis; Frailty; Physical function

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Determining recruitment as the number of randomized participants divided by the number of patients assessed for eligibility.

  1 Month

• Retention rate

  Determining retention rate by the number of randomized participants completing the 12-week follow-up divided by the total number of randomized participants

  12 Weeks

• Adherence rate

  Adherence will be quantified using two metrics. Overall session persistence will be calculated as the total number of sessions attended, including partially attended sessions, across all intervention participants divided by the total number of scheduled sessions across all intervention participants. Within-session completeness will be calculated as the percentage of prescribed exercises completed per session, excluding preparation time and skipped items.

  12 Weeks

Secondary Outcomes (3)

• Change in daily physical activity level

  Baseline and 12 Weeks

• Change in Fried frailty phenotype score

  Baseline and 12 Weeks

• Change in physical function level

  Baseline and 12 Weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

The participants in the study group will be given an online personalized exercise program at home in non dialysis days. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.

Behavioral: Home-based Exercise

Control group

NO INTERVENTION

Participants allocated to the control group will serve as a wait-list usual-care comparator. They will receive their usual nephrological care and will be instructed to maintain their usual treatment regimen and customary dietary and physical activity patterns without structured exercise during the 12-week control period. After study completion, they will be offered access to the same tele-exercise program.

Interventions

Home-based Exercise BEHAVIORAL

The participants in the study group will be given an online personalized exercise program at home in non dialysis days. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of tele-exercises will be private and the professional will send the link for each training session and will control the access of the participants. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.

Exercise group

Eligibility Criteria

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

You may qualify if:

• Being Aged 18 years and over
• Regular in-center HD 3 times a week
• Completed at least 1 year of stable HD history
• Without myocardial infarction within past 3 months
• Permission from their doctors
• Have decision making capacity to enable them to give informed consent to take part in the study
• Have access to a smart device (e.g. smart phone, laptop or tablet), and have internet access

You may not qualify if:

• Unstable cardiac status (angina, decompensated congestive heart failure, severe vascular stenosis, uncontrolled arrhythmias, etc.).
• Active infection or acute medical illness.
• Hemodynamic instability.
• Labile glycemic control.
• Unstable HD treatment or an ongoing change or titration in the medication regimen.
• Inability to exercise due to severe mobility limitations, although modifications will be permitted for amputations with prosthesis or seated exercise.
• Severe musculoskeletal pain at rest or with minimal activity.
• Inability to sit, stand, or walk unassisted (walking aids such as a cane or walker will be allowed).
• Shortness of breath at rest or during activities of daily living (NYHA Class IV).
• Participation in exercise ≥3 times per week addressing ≥2 exercise domains

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Khorshid Dialysis Center

Isfahan, Iran

Location

Related Publications (8)

• Painter PL, Nelson-Worel JN, Hill MM, Thornbery DR, Shelp WR, Harrington AR, Weinstein AB. Effects of exercise training during hemodialysis. Nephron. 1986;43(2):87-92. doi: 10.1159/000183805.

  PMID: 3713951 BACKGROUND

• Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.

  PMID: 30342464 BACKGROUND

• Hiraki K, Shibagaki Y, Izawa KP, Hotta C, Wakamiya A, Sakurada T, Yasuda T, Kimura K. Effects of home-based exercise on pre-dialysis chronic kidney disease patients: a randomized pilot and feasibility trial. BMC Nephrol. 2017 Jun 17;18(1):198. doi: 10.1186/s12882-017-0613-7.

  PMID: 28623895 BACKGROUND

• Darawad MW, Khalil AA. Jordanian dialysis patients' perceived exercise benefits and barriers: a correlation study. Rehabil Nurs. 2013 Nov-Dec;38(6):315-22. doi: 10.1002/rnj.98. Epub 2013 May 23.

  PMID: 23703743 BACKGROUND

• Rosa CS, Bueno DR, Souza GD, Gobbo LA, Freitas IF Jr, Sakkas GK, Monteiro HL. Factors associated with leisure-time physical activity among patients undergoing hemodialysis. BMC Nephrol. 2015 Nov 27;16:192. doi: 10.1186/s12882-015-0183-5.

  PMID: 26613791 BACKGROUND

• Ortega-Perez de Villar L, Martinez-Olmos FJ, Perez-Dominguez FB, Benavent-Caballer V, Montanez-Aguilera FJ, Mercer T, Segura-Orti E. Comparison of intradialytic versus home-based exercise programs on physical functioning, physical activity level, adherence, and health-related quality of life: pilot study. Sci Rep. 2020 May 19;10(1):8302. doi: 10.1038/s41598-020-64372-y.

  PMID: 32427935 BACKGROUND

• 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

• Knott S, Hollis A, Jimenez D, Dawson N, Mabbagu E, Beato M. Efficacy of Traditional Physical Therapy Versus Otago-Based Exercise in Fall Prevention for ALF-Residing Older Adults. J Geriatr Phys Ther. 2021 Oct-Dec 01;44(4):210-218. doi: 10.1519/JPT.0000000000000285.

  PMID: 33534336 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Sedentary Behavior; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  STUDY DIRECTOR

• Bobby Cheema, Dr

  School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia

  PRINCIPAL INVESTIGATOR

• Thomas Wilkinson, Dr

  Diabetes Research Centre, University of Leicester, Leicester, UK

  PRINCIPAL INVESTIGATOR

• Kenneth Wilund, Dr

  School of Nutritional Sciences and Wellness, Arizona University

  PRINCIPAL INVESTIGATOR

• Fabio Manferedini, Dr

  Dept of Neuroscience and Rehabilitation, University of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Functional outcomes in both groups will be assessed by an assessor who will be blinded to group allocation. Participants and intervention-delivery staff cannot be blinded because of the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: March 15, 2024
• Primary Completion: June 12, 2024
• Study Completion: July 2, 2024
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available after the paper is published. No end date.
• Access Criteria: Available from the corresponding author upon reasonable request, subject to institutional approval and a data-sharing agreement.

Locations

IR (1)