The Effect of Home Based Tel-Exercise on Dialysis Patients

NCT06313892 | Completed DMC

• 1 other identifier: PA24HD-2-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 by eligible number/enrolled number

  1 Month

• Retention rates

  Determining retention rate by patients who completed visit 2 / recruited patients

  3 Months

• Adherence rate

  Determining the adherence by the number of participation in exercise sessions by a participant / the number of the exercise sessions planned in the program

  3 Months

Secondary Outcomes (3)

• Rate of changes of daily physical activity level

  Pre test and 3 months later ( post test)

• Rate of changes of Frailty level

  Pre test and 3 months later ( post test)

• Rate of changes of physical function level

  Pre test and 3 months later ( post test)

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

Patients allocated to the control group will receive their standard nephrological care. Through the 12-week period, all control participants will be instructed to maintain the standard treatment regimen and to maintain their customary dietary and physical activity patterns.

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 - 80 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 arteriovenous stenosis, uncontrolled arrhythmias, etc.) 2) Active infection or acute medical illness 3) Hemodynamic instability 4) Labile glycemic control 5) Unable to exercise (lower extremity amputation with no prosthesis) 6) having severe musculoskeletal pain at rest or with minimal activity 7) Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed) 8) Having shortness of breath at rest or with activities of daily living (NYHAClass IV) 9) individuals with exercise participation ≥ 3 times per week that addressed ≥ 2 of the domains 10) Unstable HD treatment and changing (titrating) medication regime 11) Excess inter-dialytic weight gain (\>4 kg since last HD or exercise session) 12) Myocardial infarction within past 3 months

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (2)

Khorshid Dialysis Center

Isfahan, Iran

Location

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (8)

• 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

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

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

• Tomas 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: A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.
• 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: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the paper is published. No end date.
• Access Criteria: Not applicable. It will be accessible for public.

Locations

IR (2)