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End-Stage Renal DiseaseNCT06877962

The Effect of Home-based Exercise on Postural Abnormalities

A study testing Home-based Tele Exercise in people with End-Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Home-based Tele Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIran
Study dates
15 Mar 2025to 20 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Engaging in physical activity > 3 times per week at moderate to high intensity
  • Participating in regular exercise programs targeting endurance, strength, or flexibility > 3 times per week

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • Khorshid Dialysis Center

    Isfahan

Other trials in Iran

About this study

Official title: 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.

Read the 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.

Being tested
Home-based Tele Exercise
Keywords
Tele-exercise, Dialysis Patients, Postural Abnormalities, Balance and Physical Function, Frailty
Medical subject headings
Kidney Failure, Chronic, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based Tele ExerciseBehavioural

    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.

Study groups in NCT06877962
Study groupRoleWhat they receive
Exercise groupExperimentalThe 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.
Receives: Behavioral: Home-based Tele Exercise
Control groupNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of changes in hyper-kyphosis

    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.

    Measured: Pre-test and 3 Months Later (Post-test)

  2. Rate of changes in forward head posture

    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°.

    Measured: Pre-test and 3 Months Later (Post-test)

Secondary outcomes (5)
  1. Rate of changes of balance and fall risk

    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).

    Measured: Pre-test and 3 Months Later (Post-test)

  2. Rate of changes of physical function

    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.

    Measured: Pre-test and 3 Months Later (Post-test)

  3. Rate of changes of daily physical activity level

    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.

    Measured: Pre-test and 3 Months Later (Post-test)

  4. Rate of changes of fatigue levels

    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)

    Measured: Pre-test and 3 Months Later (Post-test)

  5. Rate of changes of quality of life

    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.

    Measured: Pre-test and 3 Months Later (Post-test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start15 Mar 2025
  3. Primary completion2 Jul 2025
  4. Study completion20 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877962
Sponsor's protocol ID
PA25HD-2-02
Status last verified
Aug 2025
First submitted
5 Mar 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) underlying the results reported in the published article will be shared after deidentification.

Publications

  • Myers J, Chan K, Chen Y, Lit Y, Patti A, Massaband P, Kiratli BJ, Tamura M, Chertow GM, Rabkin R. Effect of a Home-Based Exercise Program on Indices of Physical Function and Quality of Life in Elderly Maintenance Hemodialysis Patients. Kidney Blood Press Res. 2021;46(2):196-206. doi: 10.1159/000514269. Epub 2021 Mar 26.

    PubMed 33774634
  • Jirasirirak S, Disthabanchong S, Ongphiphadhanakul B, Arj-Ong Vallibhakara S, Nimitphong H. Prevalence and predictors of asymptomatic vertebral fracture in patients with end-stage renal disease. Heliyon. 2022 Mar 23;8(3):e09158. doi: 10.1016/j.heliyon.2022.e09158. eCollection 2022 Mar.

    PubMed 35368525
  • Li WY, Chau PH, Dai Y, Tiwari AF. The Prevalence and Negative Effects of Thoracic Hyperkyphosis on Chinese Community-Dwelling Older Adults in Wuhan, Hubei Province, China. J Nutr Health Aging. 2021;25(1):57-63. doi: 10.1007/s12603-020-1441-1.

    PubMed 33367463
  • Yang S, Boudier-Reveret M, Yi YG, Hong KY, Chang MC. Treatment of Chronic Neck Pain in Patients with Forward Head Posture: A Systematic Narrative Review. Healthcare (Basel). 2023 Sep 22;11(19):2604. doi: 10.3390/healthcare11192604.

    PubMed 37830641
  • de Araujo TB, de Luca Correa H, de Deus LA, Neves RVP, Reis AL, Honorato FS, da S Barbosa JM, Palmeira TRC, Aguiar SS, Sousa CV, Santos CAR, Neto LSS, Amorim CEN, Simoes HG, Prestes J, Rosa TS. The effects of home-based progressive resistance training in chronic kidney disease patients. Exp Gerontol. 2023 Jan;171:112030. doi: 10.1016/j.exger.2022.112030. Epub 2022 Nov 21.

    PubMed 36423855
  • Watanabe K, Kamijo Y, Yanagi M, Ishibashi Y, Harada T, Kohzuki M. Home-based exercise and bone mineral density in peritoneal dialysis patients: a randomized pilot study. BMC Nephrol. 2021 Mar 18;22(1):98. doi: 10.1186/s12882-021-02289-y.

    PubMed 33736592
  • Zhang F, Zhou W, Sun Q, Zhai Y, Zhang Y, Su H, Wang Z. Effects of intradialytic resistance exercises on physical performance, nutrient intake and quality of life among haemodialysis people: A systematic review and meta-analysis. Nurs Open. 2021 Mar;8(2):529-538. doi: 10.1002/nop2.274. Epub 2019 Sep 30.

    PubMed 33570280
  • Greenwood SA, Young HML, Briggs J, Castle EM, Walklin C, Haggis L, Balkin C, Asgari E, Bhandari S, Burton JO, Billany RE, Bishop NC, Bramham K, Campbell J, Chilcot J, Cooper NJ, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor Z, Taal MW, Tollit J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald JH. Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK. Lancet Digit Health. 2024 Jan;6(1):e23-e32. doi: 10.1016/S2589-7500(23)00204-2. Epub 2023 Nov 14.

    PubMed 37968170
  • Lee MK, Lee CJ, Goo SY, Lee TH, Moon JY, Jung J, Kim MJ, Shin SH, Kim JN, Han SN, Lee JE, Lee JY, Chung IM, Jeon JY. Development and application of a home-based exercise program for patients with cardiovascular disease: a feasibility study. BMC Sports Sci Med Rehabil. 2024 Feb 21;16(1):51. doi: 10.1186/s13102-024-00835-3.

    PubMed 38378630
  • Yoo HN, Chung E, Lee BH. The Effects of Augmented Reality-based Otago Exercise on Balance, Gait, and Falls Efficacy of Elderly Women. J Phys Ther Sci. 2013 Jul;25(7):797-801. doi: 10.1589/jpts.25.797. Epub 2013 Aug 20.

    PubMed 24259856

Questions about this trial

What is this clinical trial studying?

A study testing Home-based Tele Exercise in people with End-Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of changes in hyper-kyphosis (time frame: Pre-test and 3 Months Later (Post-test)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06877962, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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