The Effect of Home Based Tel-Exercise on Dialysis Patients

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Hemodialysis Complication
• Interventions: Behavioral: Home based Exercise

• Registration Number: NCT06313892
• Lead Sponsor: Pardis Specialized Wellness Institute

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-10
• Study Start: 2024-03-15
• Study First Posted: 2024-03-15
• Primary Completion: 2024-06-12
• Study Completion: 2024-07-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Home based Exercise	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.

Primary Outcome Measures

Name	Time	Method
Adherence rate	3 Months	Determining the adherence by the number of participation in exercise sessions by a participant / the number of the exercise sessions planned in the program
Recruitment rate	1 Month	Determining recruitment by eligible number/enrolled number
Retention rates	3 Months	Determining retention rate by patients who completed visit 2 / recruited patients

Secondary Outcome Measures

Name	Time	Method
Rate of changes of Frailty level	Pre test and 3 months later ( post test)	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.
Rate of changes of daily physical activity level	Pre test and 3 months later ( post test)	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.
Rate of changes of physical function level	Pre test and 3 months later ( post test)	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

Trial Locations

Locations (2)

Pardis specialized wellness institute; 🇮🇷 Isfahan, Iran, Islamic Republic of

Khorshid Dialysis Center; 🇮🇷 Isfahan, Iran, Islamic Republic of