The Effect of Home Based Tele-Exercise on Peritoneal Dialysis Patients

NCT06787599 | Completed DMC

• 1 other identifier: PA25PD-2-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: The objective of the trial is to assess the effect of synchronous home-based tele exercise on daily activity level, functional status and frailty level in Peritoneal Dialysis patients. Condition or disease Intervention/treatment End Stage Renal Disease Peritoneal Dialysis Complication Behavioral: Home-based Tele Exercise

Conditions

End Stage Renal Disease; Peritoneal Dialysis Complication

Keywords

Tele-exercise; Peritoneal; Dialysis Patients; Frailty; Physical function

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Determining recruitment by eligible number/enrolled number

  1 Month

• Retention rate

  Determining retention rate by patients who completed visit 2 / recruited patients

  3 Months

• Adherence rate

  Determining the adherence by the number of participation in exercise sessions by a participant / the number of the exercise sessions planned in the program

  3 Months

• Goal Achievement Scale (GAS)

  Using GAS to individually evaluate the effect of the intervention, accounting for differences in disease stages and personalized goals.

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

Secondary Outcomes (3)

• Rate of changes of daily physical activity level

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

• Rate of changes of Frailty level

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

• Rate of changes of physical function level

  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 non-peritoneal dialysis (PD). 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 non-peritoneal dialysis (PD) days. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of teleexercises will be private and the professional will send the link for each training session and will control the access of the participants. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.

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

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 (23)

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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

• Paul Bennett, Prof

  Griffith University

  STUDY DIRECTOR

• Farzad Nazemi

  Pardis Specialized Wellness Institute

  STUDY DIRECTOR

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. 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: January 16, 2025
• First Posted: January 22, 2025
• Study Start: January 29, 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)