The Effect of Home Based Tel-Exercise on Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

The Effect of Synchronous Home Based Tele Exercise on Physical Function, Daily Physical Activity and Frailty in Dialysis Patients: A Randomized Pilot Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06313892
• Other study ID #: PA24HD-2-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Pardis Specialized Wellness Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with renal failure undergoing maintenance dialysis (HD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality.

According to studies, regular exercise is beneficial for patients at all stages, and the current recommendations for the prevention and management of side effects in HD patients, especially in the elderly, is regular exercise because it improves physical performance and PA . Currently, due to the unfamiliarity of dialysis center staff and nephrologists with the benefits of exercise, only 10% of the world's clinics have a plan to exercise during HD. Therefore, home-based exercise programs are a suitable option for patients to reduce their costs and make it easy to adhere to.

Home-based exercise has the potential to utilize higher volume and higher intensity training if activity is monitored. However, many of these programs are unsupervised and this is one of the major disadvantages of home-based exercise programs. Lack of prior knowledge about the safety and benefits of exercise programs, fear of injury, and lack of interest or motivation are barriers to exercise at home.

Tele-rehabilitation is rehabilitation services provided to patients from distant locations using information and communication technologies.Several studies have reported the use of e health-based self-management interventions in chronic kidney disease patients.

However, further research is needed to better understand the extent to which these techniques are acceptable, safe and potentially effective for supporting individuals undergoing HD treatment, given their unique needs and risk profile, is unknown. Our study seeks to address this gap by conducting a pilot evaluation of synchronous home-based tele exercise intervention designed for HD patient.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. being Aged 18 years and over

2. Regular in-center HD 3 times a week

3. completed at least 1 year of stable HD history

4. Without myocardial infarction within past 3 months

5. permission from their doctors

6. have decision making capacity to enable them to give informed consent to take part in the study

7. have access to a smart device (e.g. smart phone, laptop or tablet), and have internet access

Exclusion Criteria:

1) 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

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Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Complication
• Kidney Failure, Chronic

Intervention

Behavioral:
• Home based Exercise
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Khorshid Dialysis Center	Isfahan
Iran, Islamic Republic of	Pardis specialized wellness institute	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Pardis Specialized Wellness Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (8)

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 tr — View Citation

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. — View Citation

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: 10.118 — View Citation

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. — View Citation

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. Erratum In: J Am Soc Nephrol. 2018 Jul;29(7):2028. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Determining recruitment by eligible number/enrolled number	1 Month
Primary	Retention rates	Determining retention rate by patients who completed visit 2 / recruited patients	3 Months
Primary	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	Rate of changes of daily physical activity level	To examine the effect of home-based synchronous tele-exercise on daily activity level by using Low Physical activity questionnaire.; The questionnaire consists of 11 items that assess various parameters of physical activity within the past 7 days. These parameters include the amount of time spent walking around the neighborhood, for fitness or pleasure, and for transportation purposes, as well as the average duration of sedentary and sitting activities. The questionnaire also calculates the kilocalories expended during light, moderate, vigorous, and total physical activities.	Pre test and 3 months later ( post test)
Secondary	Rate of changes of Frailty level	To examine the effect of home-based synchronous tele-exercise on daily activity level by using Fried Frailty Index.; Patients will be considered frail if they met 3 or more of the following 5 criteria: unintentional weight loss of 10 pounds or more in the prior year by self-report; exhaustion based on responses to two questions about energy; low physical activity based on the Minnesota questionnaire (< 383 kcal/wk for men or < 270 kcal/wk for women); slow gait speed (based on gender- and height-stratified cutoffs); and weak grip strength (based on gender- and BMI-stratified cutoffs). Patients will be asked whether they are independent in the following activities of daily living (ADLs): bathing, dressing, getting in and out of a chair, and walking around their home or apartment. Those reporting dependency in one or more will be considered to have an ADL limitation.	Pre test and 3 months later ( post test)
Secondary	Rate of changes of physical function level	To examine the effect of home-based synchronous tele-exercise on physical function level by 6 minute walk test and short physical performance battery test	Pre test and 3 months later ( post test)