Clinical trial NCT06877962: The Effect of Home-based Exercise on Postural Abnormalities
Official title: The Effect of Home-based Exercise on Postural Abnormalities of Dialysis Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-Stage Renal Disease
Hemodialysis Complication
Keywords: Tele-exercise
Dialysis Patients
Postural Abnormalities
Balance and Physical Function
Frailty
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effects of synchronous home-based tele-exercise on postural abnormalities (FHP and hyper-kyphosis) in dialysis patients. It aims to assess improvements in balance, physical function, and quality of life while reducing fatigue and fall risk.

Detailed description: End-stage renal disease, as one of the serious problems of public health, can significantly influence Musco skeletal system, physical unction and quality of life in dialysis patients. As a result of the treatment limitations, dialysis patients often suffer from postural abnormalities such as hyper-kyphosis and forward head posture (FHP), directly impacting their balance, daily physical activities and fall risk. Such physical issues, coupled with reduced balance and physical capacity can significantly increase the risk of serious injuries such as fractures of hip and spine.

Kyphosis, an abnormal curvature of the spine, result in noticeable changes not only in the pulmonary function but also in the cardiopulmonary capacity. Furthermore, FHP, the forward displacement of the head in the sagittal plane relative to the shoulders, lead to muscular imbalances including the shortening and tightening of the upper trapezius as well as the weakening of the deep flexor muscles of neck around the cervical spine. In addition to affecting body balance and stability, this condition result in a number of problems such as the neck pain, functional disorders and tension headaches. Main factors contributing to those abnormalities include muscular weakness, reduced bone density and a sedentary life style exacerbated by the specific nature of dialysis treatment. Dialysis patients are also at a higher risk of sarcopenia and osteoporosis subsequently affecting their mobility and risk of falls.

Regular exercises, especially home-based ones, could positively influence postural abnormalities and physical function in dialysis patients. Studies have shown that home-based resistance and aerobic exercises improve bone density, standing balance and physical function. Such programs are considered a suitable option for dialysis patients as a result of their ease of implementation as well as the diminished costs associated with visiting the medical centers.

Despite numerous evidence on the positive effect of exercise on dialysis patients, there is not sufficient research on the effect of home-based exercises on hyper-kyphosis and FHP. Particularly, the effect of such programs on dynamic balance require further investigation. Additionally, only a few studies have comprehensively evaluated the weakness and fatigue indicators in these patients.

To improve the effectiveness of home-based exercises, they should be tailored to the patients' personal requirements. These programs can significantly increase the life quality, aerobic capacity and balance indicators despite the challenge of low retention rate.

The investigators hypothesize that synchronous home-based tele-exercise would have a positive impact on reducing the prevalence of physical abnormalities, including FHP and hyper kyphosis, in dialysis patients. The investigators also expect an improvement in their physical function, balance and quality of life while decreasing fatigue.

In this study, the investigators aim to investigate how home-based exercises affect the prevalence of hyper-kyphosis and FHP in dialysis patients. Additionally using standard methods, the investigators evaluate the impact of these abnormalities on patients' balance and physical function and present preventive solutions to reduce fall risks. As for the secondary goals, the investigators aim to evaluate the final effects on quality of life and fatigue indices of hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years and over
2. At least 3 months of stable peritoneal dialysis (PD) history
3. Permission from their doctors
4. Have decision-making capacity to enable them to give informed consent to take part in the study
5. Have access to a smart device (e.g., smartphone, laptop or tablet), and have internet access
6. Engaging in physical activity \> 3 times per week at moderate to high intensity
7. Participating in regular exercise programs targeting endurance, strength, or flexibility \> 3 times per week

Exclusion Criteria:

1. Unstable cardiac status, including angina, decompensated congestive heart failure, or uncontrolled arrhythmias
2. Active infection or acute medical illness
3. Hemodynamic instability
4. Labile glycemic control
5. Individuals unable to exercise entirely, e.g., lower extremity amputations without feasible alternatives for adapted exercise
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. Myocardial infarction within the past 3 months

Primary outcomes:
measure: Rate of changes in hyper-kyphosis
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes in forward head posture
timeFrame: Pre-test and 3 Months Later (Post-test)
Secondary outcomes:
measure: Rate of changes of balance and fall risk
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes of physical function
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes of daily physical activity level
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes of fatigue levels
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes of quality of life
timeFrame: Pre-test and 3 Months Later (Post-test)
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid Dialysis Center
Study officials:
affiliation: Pardis Specialized Wellness Institute
name: Mohammad Ali Tabibi, Dr
role: PRINCIPAL_INVESTIGATOR
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