The Effect of Synchronous Homebased Tele-exercise on Physical Function, Daily Physical Activity and Frailty in Peritoneal Dialysis Patients: A Randomized Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Recruitment rate
Study Overview
Brief Summary
Brief Summary:
The objective of the trial is to assess the effect of synchronous home-based tele exercise on daily activity level, functional status and frailty level in Peritoneal Dialysis patients.
Condition or disease Intervention/treatment End Stage Renal Disease Peritoneal Dialysis Complication Behavioral: Home-based Tele Exercise
Detailed Description
Patients with renal failure undergoing peritoneal dialysis (PD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality. Although PD prevents premature death of patients, it can lead to many complications. During the years of treatment, they suffer from various problems such as malnutrition, reduced physical performance, reduced aerobic capacity, low quality of life and inactivity, so that the activity level physical activity of these patients is significantly lower than that of healthy people.
According to studies, regular exercise is beneficial for patients at all stages of renal disease, and the current recommendations for the prevention and management of side effects in PD patients, especially in the elderly, is regular exercise because it improves physical performance and PA.
There are several barriers to participation in PA for people with chronic kidney disease (CKD), especially those who are undergoing PD treatment that prevent them from adopting a consistent exercise program. These include issues specific to PD such as the risk of peritonitis, the need for aseptic technique during bag changes, and the physical discomfort associated with carrying dialysate. Personal issues that prevent participation in PA include lack of knowledge about appropriate exercise and its benefits, and lack of energy or motivation.
To increase activity levels, clinicians and researchers have experimented with different types of interventions, including home-based exercise programs, which are a suitable option for PD 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 by a coach. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years and over
- •At least 3 months of stable peritoneal dialysis (PD) history
- •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., smartphone, laptop or tablet), and have internet access
Exclusion Criteria
- •Unstable cardiac status, including angina, decompensated congestive heart failure, or uncontrolled arrhythmias
- •Active infection or acute medical illness
- •Hemodynamic instability
- •Labile glycemic control
- •Individuals unable to exercise entirely, e.g., lower extremity amputations without feasible alternatives for adapted exercise
- •Having severe musculoskeletal pain at rest or with minimal activity
- •Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed)
- •Having shortness of breath at rest or with activities of daily living (NYHAClass IV)
- •Individuals with exercise participation ≥ 3 times per week that addressed ≥ 2 of the domains
- •Myocardial infarction within the past 3 months
Arms & Interventions
Exercise group
The participants (n = 15) in the study group will be given an online personalized exercise program at home in non-peritoneal dialysis (PD). Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.
Intervention: Home-based Tele Exercise (Behavioral)
Control group
Patients allocated to the control group (n = 15) 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.
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: 1 Month
Determining recruitment by eligible number/enrolled number
Retention rate
Time Frame: 3 Months
Determining retention rate by patients who completed visit 2 / recruited patients
Adherence rate
Time Frame: 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
Goal Achievement Scale (GAS)
Time Frame: Pre-test and 3 Months Later (Post-test)
Using GAS to individually evaluate the effect of the intervention, accounting for differences in disease stages and personalized goals.
Secondary Outcomes
- 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))