End Stage Renal Disease, Hemodialysis Complication
Conditions
Keywords
Inactivity, Tele-exercise, Home-based exercise, Hemodialysis, Frailty, Physical function
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. Participants were recruited and clinically assessed at Khorshid Dialysis Center in Isfahan, Iran. Eligibility screening and baseline and post-intervention clinical assessments were conducted at Khorshid Dialysis Center. The Pardis Specialized Wellness Institute served as the study sponsor and coordinated the study procedures and the design of the home-based tele-exercise intervention. The synchronous tele-exercise intervention was prescribed, coordinated, and delivered online by the Pardis Specialized Wellness Institute.
Interventions
BEHAVIORALHome-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.
Sponsors
Pardis Specialized Wellness Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 vascular stenosis, uncontrolled arrhythmias, etc.). 2. Active infection or acute medical illness. 3. Hemodynamic instability. 4. Labile glycemic control. 5. Unstable HD treatment or an ongoing change or titration in the medication regimen. 6. Inability to exercise due to severe mobility limitations, although modifications will be permitted for amputations with prosthesis or seated exercise. 7. Severe musculoskeletal pain at rest or with minimal activity. 8. Inability to sit, stand, or walk unassisted (walking aids such as a cane or walker will be allowed). 9. Shortness of breath at rest or during activities of daily living (NYHA Class IV). 10. Participation in exercise ≥3 times per week addressing ≥2 exercise domains
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 1 Month | Determining recruitment as the number of randomized participants divided by the number of patients assessed for eligibility. |
| Retention rate | 12 Weeks | Determining retention rate by the number of randomized participants completing the 12-week follow-up divided by the total number of randomized participants |
| Adherence rate | 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in daily physical activity level | Baseline and 12 Weeks | 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. |
| Change in Fried frailty phenotype score | Baseline and 12 Weeks | To examine the effect of home-based synchronous tele-exercise on change in Fried frailty phenotype score. Frailty will be assessed using the Fried frailty phenotype, based on five 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 self-reported frequency of mildly, moderately, and very energetic activity, with low physical activity considered present when both moderately and very energetic activities were reported as occurring hardly ever or never; slow gait speed based on gender- and height-stratified cutoffs; and weak grip strength based on gender- and BMI-stratified cutoffs. |
| Change in physical function level | Baseline and 12 Weeks | 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 |
Countries
Iran
Contacts
STUDY_DIRECTORMohammad Ali Tabibi, Dr
Pardis Specialized Wellness Institute
PRINCIPAL_INVESTIGATORBobby Cheema, Dr
School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia
PRINCIPAL_INVESTIGATORThomas Wilkinson, Dr
Diabetes Research Centre, University of Leicester, Leicester, UK
PRINCIPAL_INVESTIGATORKenneth Wilund, Dr
School of Nutritional Sciences and Wellness, Arizona University
PRINCIPAL_INVESTIGATORFabio Manferedini, Dr
Dept of Neuroscience and Rehabilitation, University of Ferrara
Outcome results
None listed