The Effect of Home Based Tel-Exercise on Dialysis Patients

NCT ID: NCT06313892

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2024-07-02

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.

Conditions

End Stage Renal Disease; Hemodialysis Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise group

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.

Group Type: EXPERIMENTAL

Home based Exercise

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pardis Specialized Wellness Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohammad Ali Tabibi, Dr

Role: STUDY_DIRECTOR

Pardis Specialized Wellness Institute

Bobby Cheema, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Tomas Wilkinson, Dr

Role: PRINCIPAL_INVESTIGATOR

Diabetes Research Centre, University of Leicester, Leicester, UK

Kenneth Wilund, Dr

Role: PRINCIPAL_INVESTIGATOR

School of Nutritional Sciences and Wellness, Arizona University

Fabio Manferedini, Dr

Role: PRINCIPAL_INVESTIGATOR

Dept of Neuroscience and Rehabilitation, University of Ferrara

Locations

Khorshid Dialysis Center

Isfahan, , Iran

Pardis specialized wellness institute

Isfahan, , Iran

Countries

Iran

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

PA24HD-2-05

Identifier Type: -

Identifier Source: org_study_id