The Effect of Home-based Exercise on Postural Abnormalities

NCT ID: NCT06877962

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2025-07-20

Brief Summary

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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

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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.

Conditions

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End-Stage Renal Disease Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test and postural abnormalities assessments. 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.

Study Groups

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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.

Group Type EXPERIMENTAL

Home-based Tele Exercise

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pardis Specialized Wellness Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Ali Tabibi, Dr

Role: PRINCIPAL_INVESTIGATOR

Pardis Specialized Wellness Institute

Locations

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Khorshid Dialysis Center

Isfahan, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 33774634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35368525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33367463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37830641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36423855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33736592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33570280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37968170 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38378630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24259856 (View on PubMed)

Other Identifiers

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PA25HD-2-02

Identifier Type: -

Identifier Source: org_study_id

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