The Effect of Home-based Exercise on Postural Abnormalities

August 11, 2025 updated by: Pardis Specialized Wellness Institute

The Effect of Home-based Exercise on Postural Abnormalities of Dialysis Patient

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
The participants (n = 15) in the study group will be given an online personalized exercise program at home in hemodialysis (HD). Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.
Behavioral: Home-based Tele Exercise
The participants in the study group will be given an online personalized exercise program at home in hemodialysis (HD) 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of changes in hyper-kyphosis
Time Frame: Pre-test and 3 Months Later (Post-test)
Evaluating the effect of home-based exercise on hyper-kyphosis using the Debrunner Kyphometer, a non-radiologic gold standard tool. This device measures the kyphosis angle by positioning its arms on the spinous processes of T2-T3 (upper point) and T11-T12 (lower point), with direct angle readings from the calibrated scale. Measurements are taken in degrees, with hyper-kyphosis defined as ≥53° in women and ≥55° in men.
Pre-test and 3 Months Later (Post-test)
Rate of changes in forward head posture
Time Frame: Pre-test and 3 Months Later (Post-test)
Evaluating the effect of home-based exercise on forward head posture craniocervical angle (CVA) analysis using digital photogrammetry. Reflective markers are placed on the C7 spinous process and the tragus of the ear, followed by lateral image capture at a standardized 1.5-meter distance. Image analysis software, such as Kinovea, automatically calculates the CVA angle. A normal posture is defined as CVA ≥53°, while a severe forward head posture is <50°.
Pre-test and 3 Months Later (Post-test)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of changes of balance and fall risk
Time Frame: Pre-test and 3 Months Later (Post-test)
Assessing balance improvements and fall risk reduction using Timed Up and Go (TUG) Test duration (unit: seconds, Time required to rise, walk 3 meters, turn, and return; diagnostic threshold ≥12 seconds indicates fall risk).
Pre-test and 3 Months Later (Post-test)
Rate of changes of physical function
Time Frame: Pre-test and 3 Months Later (Post-test)
Evaluating physical function improvement using the 6-minute walk test (6MWT), which measures the maximum distance covered in 6 minutes (unit: meters). Reference values: 400-700 meters for older adults and 150-346 meters for heart failure patients.
Pre-test and 3 Months Later (Post-test)
Rate of changes of daily physical activity level
Time Frame: Pre-test and 3 Months Later (Post-test)
Assessing the effect of home-based exercise on daily activity levels using the LowPAQ questionnaire which evaluates physical activity across occupational, transportation, household, leisure, and sedentary domains, with scoring in MET-minutes per week for light (3.3 MET), moderate (4.0 MET), and vigorous (8.0 MET) activities. Activity levels are categorized as low (<600 MET-min/week), active (600-3000 MET-min/week), and highly active (>3000 MET-min/week), aligned with WHO guidelines.
Pre-test and 3 Months Later (Post-test)
Rate of changes of fatigue levels
Time Frame: Pre-test and 3 Months Later (Post-test)
Measuring fatigue levels before and after the intervention using Fatigue Severity Scale (FSS) (9 items on a Likert scale 1-7 (total range 9-63); Score interpretation: ≥36 indicates clinical fatigue, ≤18 indicates no fatigue. ICC = 0.91)
Pre-test and 3 Months Later (Post-test)
Rate of changes of quality of life
Time Frame: Pre-test and 3 Months Later (Post-test)
Evaluating improvements in quality of life using the KDQOL-36 questionnaire, which includes SF-12 (general health, reported as a T-score with a mean of 50) and kidney disease-specific subscales: burden of kidney disease (0-100), symptoms and problems (0-100), and effects of kidney disease (0-100). The Kidney Summary Score (KSS) is calculated as the average of the three kidney-specific subscales.
Pre-test and 3 Months Later (Post-test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pardis Specialized Wellness Institute

Investigators

  • Principal Investigator: Mohammad Ali Tabibi, Dr, Pardis specialized wellness institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Actual)

July 2, 2025

Study Completion (Actual)

July 20, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA25HD-2-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) underlying the results reported in the published article will be shared after deidentification.

IPD Sharing Time Frame

The data will be available after the paper is published. No end date

IPD Sharing Access Criteria

Not applicable. It will be accessible for public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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