The Effect of Home-based Exercise on Postural Abnormalities

NCT06877962 | Completed DMC

• 1 other identifier: PA25HD-2-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease; Hemodialysis Complication

Keywords

Tele-exercise; Dialysis Patients; Postural Abnormalities; Balance and Physical Function; Frailty

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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°.

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

Secondary Outcomes (5)

• Rate of changes of balance and fall risk

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

• Rate of changes of physical function

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

• Rate of changes of daily physical activity level

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

• Rate of changes of fatigue levels

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

• Rate of changes of quality of life

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

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Home-based Tele Exercise 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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Khorshid Dialysis Center

Isfahan, Iran

Location

Related Publications (10)

• 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.

  PMID: 33774634 BACKGROUND

• 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.

  PMID: 35368525 BACKGROUND

• 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.

  PMID: 33367463 BACKGROUND

• 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.

  PMID: 37830641 BACKGROUND

• 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.

  PMID: 36423855 BACKGROUND

• 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.

  PMID: 33736592 BACKGROUND

• 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.

  PMID: 33570280 BACKGROUND

• 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.

  PMID: 37968170 BACKGROUND

• 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.

  PMID: 38378630 BACKGROUND

• 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.

  PMID: 24259856 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Ali Tabibi, Dr

  Pardis Specialized Wellness Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 14, 2025
• Study Start: March 15, 2025
• Primary Completion: July 2, 2025
• Study Completion: July 20, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the paper is published. No end date
• Access Criteria: Not applicable. It will be accessible for public

Locations

IR (1)