AzTrials
AzTrials

End Stage Renal DiseaseNCT06787599

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

A study testing Home-based Tele Exercise in people with End Stage Renal Disease and Peritoneal Dialysis 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
Search all trials

Trial 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. 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
29 Jan 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

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 Synchronous Homebased Tele-exercise on Physical Function, Daily Physical Activity and Frailty in Peritoneal Dialysis Patients: A Randomized Pilot Trial

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

Read the detailed description

Patients with renal failure undergoing peritoneal dialysis (PD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality. Although PD prevents premature death of patients, it can lead to many complications. During the years of treatment, they suffer from various problems such as malnutrition, reduced physical performance, reduced aerobic capacity, low quality of life and inactivity, so that the activity level physical activity of these patients is significantly lower than that of healthy people.

According to studies, regular exercise is beneficial for patients at all stages of renal disease, and the current recommendations for the prevention and management of side effects in PD patients, especially in the elderly, is regular exercise because it improves physical performance and PA.

There are several barriers to participation in PA for people with chronic kidney disease (CKD), especially those who are undergoing PD treatment that prevent them from adopting a consistent exercise program. These include issues specific to PD such as the risk of peritonitis, the need for aseptic technique during bag changes, and the physical discomfort associated with carrying dialysate. Personal issues that prevent participation in PA include lack of knowledge about appropriate exercise and its benefits, and lack of energy or motivation.

To increase activity levels, clinicians and researchers have experimented with different types of interventions, including home-based exercise programs, which are a suitable option for PD patients to reduce their costs and make it easy to adhere to.

Home-based exercise has the potential to utilize higher volume and higher intensity training if activity is monitored by a coach. However, many of these programs are unsupervised and this is one of the major disadvantages of home-based exercise programs. Lack of prior knowledge about the safety and benefits of exercise programs, fear of injury, and lack of interest or motivation are barriers to exercise at home.

Tele-rehabilitation is rehabilitation services provided to patients from distant locations using information and communication technologies. Tele rehabilitation consultations may include diagnosis, assessment, education, therapy, goal setting, and monitoring. Literature reviews on telerehabilitation practices in the older people have shown that tele-rehabilitation can produce results similar to face-to-face methods.

Communication between patients and rehabilitation specialists takes place through a variety of synchronous approaches such as telephony, internet-based video conferencing, or asynchronous methods like video-based exercise. E-Health interventions utilizing some of these techniques to support prostate, colorectal, breast and leukemia cancer populations have already been trialed with good effects in terms of improved PA levels and reduced sedentary behavior. Several studies have reported the use of eHealth-based self-management interventions in CKD patients.

However, further research is needed to better understand the extent to which these techniques are acceptable, safe and potentially effective for supporting individuals undergoing PD treatment, given their unique needs and risk profile, is unknown. Our study seeks to address this gap by conducting a pilot evaluation of synchronous home-based tele exercise intervention designed for PD patient.

Being tested
Home-based Tele Exercise
Keywords
Tele-exercise, Peritoneal, Dialysis Patients, Frailty, Physical function
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 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.

Study groups in NCT06787599
Study groupRoleWhat they receive
Exercise groupExperimentalThe 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.
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. Recruitment rate

    Determining recruitment by eligible number/enrolled number

    Measured: 1 Month

  2. Retention rate

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

    Measured: 3 Months

  3. 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

    Measured: 3 Months

  4. Goal Achievement Scale (GAS)

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

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

Secondary outcomes (3)
  1. Rate of changes of daily physical activity level

    To examine the effect of home-based synchronous tele-exercise on daily activity level by using Low Physical activity questionnaire.

    The questionnaire consists of 11 items that assess various parameters of physical activity within the past 7 days. These parameters include the amount of time spent walking around the neighborhood, for fitness or pleasure, and for transportation purposes, as well as the average duration of sedentary and sitting activities. The questionnaire also calculates the kilocalories expended during light, moderate, vigorous, and total physical activities.

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

  2. Rate of changes of Frailty level

    To examine the effect of home-based synchronous tele-exercise on daily activity level by using Fried Frailty Index.

    Patients will be considered frail if they met 3 or more of the following 5 criteria: unintentional weight loss of 10 pounds or more in the prior year by self-report; exhaustion based on responses to two questions about energy; low physical activity based on the Minnesota questionnaire (< 383 kcal/wk for men or < 270 kcal/wk for women); slow gait speed (based on gender- and height-stratified cutoffs); and weak grip strength (based on gender- and BMI-stratified cutoffs). Patients will be asked whether they are independent in the following activities of daily living (ADLs): bathing, dressing, getting in and out of a chair, and walking around their home or apartment. Those reporting dependency in one or more will be considered to have an ADL limitation.

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

  3. Rate of changes of physical function level

    To examine the effect of home-based synchronous tele-exercise on physical function level by 6 minute walk test and short physical performance battery test

    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 posted22 Jan 2025
  2. Study start29 Jan 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
NCT06787599
Sponsor's protocol ID
PA25PD-2-01
Status last verified
Aug 2025
First submitted
16 Jan 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

  • Johansen KL, Kaysen GA, Dalrymple LS, Grimes BA, Glidden DV, Anand S, Chertow GM. Association of physical activity with survival among ambulatory patients on dialysis: the Comprehensive Dialysis Study. Clin J Am Soc Nephrol. 2013 Feb;8(2):248-53. doi: 10.2215/CJN.08560812. Epub 2012 Nov 2.

    PubMed 23124787
  • Delgado C, Johansen KL. Barriers to exercise participation among dialysis patients. Nephrol Dial Transplant. 2012 Mar;27(3):1152-7. doi: 10.1093/ndt/gfr404. Epub 2011 Jul 26.

    PubMed 21795245
  • Tao X, Chow SK, Wong FK. A nurse-led case management program on home exercise training for hemodialysis patients: A randomized controlled trial. Int J Nurs Stud. 2015 Jun;52(6):1029-41. doi: 10.1016/j.ijnurstu.2015.03.013. Epub 2015 Mar 26.

    PubMed 25840898
  • Painter PL, Nelson-Worel JN, Hill MM, Thornbery DR, Shelp WR, Harrington AR, Weinstein AB. Effects of exercise training during hemodialysis. Nephron. 1986;43(2):87-92. doi: 10.1159/000183805.

    PubMed 3713951
  • Barcellos FC, Santos IS, Umpierre D, Bohlke M, Hallal PC. Effects of exercise in the whole spectrum of chronic kidney disease: a systematic review. Clin Kidney J. 2015 Dec;8(6):753-65. doi: 10.1093/ckj/sfv099. Epub 2015 Oct 20.

    PubMed 26613036
  • Baggetta R, D'Arrigo G, Torino C, ElHafeez SA, Manfredini F, Mallamaci F, Zoccali C, Tripepi G; EXCITE Working group. Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: a secondary analysis of the EXCITE trial. BMC Geriatr. 2018 Oct 20;18(1):248. doi: 10.1186/s12877-018-0938-5.

    PubMed 30342464
  • Hiraki K, Shibagaki Y, Izawa KP, Hotta C, Wakamiya A, Sakurada T, Yasuda T, Kimura K. Effects of home-based exercise on pre-dialysis chronic kidney disease patients: a randomized pilot and feasibility trial. BMC Nephrol. 2017 Jun 17;18(1):198. doi: 10.1186/s12882-017-0613-7.

    PubMed 28623895
  • Darawad MW, Khalil AA. Jordanian dialysis patients' perceived exercise benefits and barriers: a correlation study. Rehabil Nurs. 2013 Nov-Dec;38(6):315-22. doi: 10.1002/rnj.98. Epub 2013 May 23.

    PubMed 23703743
  • Rosa CS, Bueno DR, Souza GD, Gobbo LA, Freitas IF Jr, Sakkas GK, Monteiro HL. Factors associated with leisure-time physical activity among patients undergoing hemodialysis. BMC Nephrol. 2015 Nov 27;16:192. doi: 10.1186/s12882-015-0183-5.

    PubMed 26613791
  • Bennett PN, Bohm C, Harasemiw O, Brown L, Gabrys I, Jegatheesan D, Johnson DW, Lambert K, Lightfoot CJ, MacRae J, Meade A, Parker K, Scholes-Robertson N, Stewart K, Tarca B, Verdin N, Wang AY, Warren M, West M, Zimmerman D, Li PK, Thompson S. Physical activity and exercise in peritoneal dialysis: International Society for Peritoneal Dialysis and the Global Renal Exercise Network practice recommendations. Perit Dial Int. 2022 Jan;42(1):8-24. doi: 10.1177/08968608211055290. Epub 2021 Nov 7.

    PubMed 34743628
  • 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
  • Ortega-Perez de Villar L, Martinez-Olmos FJ, Perez-Dominguez FB, Benavent-Caballer V, Montanez-Aguilera FJ, Mercer T, Segura-Orti E. Comparison of intradialytic versus home-based exercise programs on physical functioning, physical activity level, adherence, and health-related quality of life: pilot study. Sci Rep. 2020 May 19;10(1):8302. doi: 10.1038/s41598-020-64372-y.

    PubMed 32427935
  • Manfredini F, Mallamaci F, D'Arrigo G, Baggetta R, Bolignano D, Torino C, Lamberti N, Bertoli S, Ciurlino D, Rocca-Rey L, Barilla A, Battaglia Y, Rapana RM, Zuccala A, Bonanno G, Fatuzzo P, Rapisarda F, Rastelli S, Fabrizi F, Messa P, De Paola L, Lombardi L, Cupisti A, Fuiano G, Lucisano G, Summaria C, Felisatti M, Pozzato E, Malagoni AM, Castellino P, Aucella F, Abd ElHafeez S, Provenzano PF, Tripepi G, Catizone L, Zoccali C. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2017 Apr;28(4):1259-1268. doi: 10.1681/ASN.2016030378. Epub 2016 Dec 1.

    PubMed 27909047
  • Velayati F, Ayatollahi H, Hemmat M. A Systematic Review of the Effectiveness of Telerehabilitation Interventions for Therapeutic Purposes in the Elderly. Methods Inf Med. 2020 May;59(2-03):104-109. doi: 10.1055/s-0040-1713398. Epub 2020 Jul 6.

    PubMed 32629502
  • Laver KE, Schoene D, Crotty M, George S, Lannin NA, Sherrington C. Telerehabilitation services for stroke. Cochrane Database Syst Rev. 2013 Dec 16;2013(12):CD010255. doi: 10.1002/14651858.CD010255.pub2.

    PubMed 24338496

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 Peritoneal Dialysis 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 5 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?

Recruitment rate (time frame: 1 Month). The study lists 4 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 NCT06787599, which also lists 23 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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in