Telerehabilitation on Physical Fitness, Functional Status, and Quality of Life in Frail Older Adults

NCT06784245 | Not Yet Recruiting

• 2 other identifiers: F. iniciacion n°1124053211240532
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial (RCT) is to analyze whether the effectiveness of a synchronous telerehabilitation program is better than a face-to-face physical therapy program in improving the physical fitness, functional status, and quality of life in frail male and female volunteers aged 60 years or older living in the community and haven frailty according to the modified Fried phenotype scale. The main research questions are: 1) Is a synchronous telerehabilitation program effective in improving the physical fitness, functional status and quality of life of frail older people?; 2) Is a synchronous telerehabilitation program more effective in improving the physical fitness, functional status and quality of life, compared to face-to-face physical therapy program, in frail older adults? In synchronous telerehabilitation program group, a healthcare professional will supervise up to four or five participants remotely exercising at home during each session, using a real-time videoconferencing app. Participants will be able to see and talk to both the health professional and the other participants. The exercise program will consist of 1-hour sessions carried out twice a week for 12 weeks. In the face-to-face physical therapy group, the exercise sessions will take place in a older person care center, which will also last 1 hour twice a week for 12 weeks. Regardless of the group, exercise sessions will include a mixture of cardiovascular, balance, strength, flexibility, and gait exercises.

Conditions

Frailty At Older Adults

Keywords

Older person; Fragility; Telerehabilitation; Physical fitness; Functional status; Quality of life

Outcome Measures

Primary Outcomes (2)

• Lower limb strength

  Will be measured using a five-repetition sit-to-stand test. The OAs will be asked to stand up and sit down, as quickly as possible, five times, from a chair without armrests located on a wall. The time will be measured from the beginning of the movement until the OA manages to stand up for the fifth time. The older adult's arms should be crossed over the chest during the test. The time will be recorded in seconds, and tenths of a second.

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

• Cardiorespiratory fitness

  Will be measured by a 2-minutes step test: The evaluator will count the number of full steps completed by the participant in 2 minutes. A full step is defined as a step performed while raising the knee up to a height corresponding to the midpoint between the patella and the iliac crest.

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

Secondary Outcomes (6)

• Upper limb strength

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

• Dynamic balance

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

• Static balance

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

• Quality of life

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

• Functional status

  Both groups will be face-to-face assessed one week before and after the 12-week intervention.

Other Outcomes (1)

• Sociodemographic background

  Both groups will be assessed in person one week prior to the 12-week intervention.

Study Arms (2)

Synchronous telerehabilitation program (STR Group)

EXPERIMENTAL

During each session, a technical staff member will supervise up to four or five participants who are exercising remotely at home using a real-time videoconferencing app (Zoom®, CA, USA). The videoconference session will be projected on a television screen located in an older adult's care centre. Participants will be able to see and talk to the healthcare professional and other participants. The older adults, from their homes, will complete 1-hour sessions twice a week for 12 weeks.

Behavioral: TeleActivate

Face-to-face physical therapy program (FPT Group)

ACTIVE COMPARATOR

The face-to-face exercise sessions will take place in a senior centre for older person, lasting 40-60 min, twice a week for 12 weeks.

Behavioral: TeleActivate

Interventions

TeleActivate BEHAVIORAL

Each session will consist of a warm-up activity (5-10 min), main exercise activity (30-40 min), and cool-down activity (5-10 min) following the guidelines of multicomponent exercise program Vivifrail. Exercise intensity will be controlled based on the Rating of Perceived Exertion (RPE) on the Borg scale and heart rate measured with a smartwatch before, during, and after each exercise session according to the guidelines of the American College of Sports Medicine (ACSM), as explained below. The warm-up and cool-down activities will include stretching and walking in place (9≤RPE≤10 and 40\<55% maximum Heart rate (HRmax). While the main exercise activity will consist of strength, resistance exercise, cardiovascular exercises, and balance exercises (to avoid falls) performed using dumbbells, colour-coded resistance bands (Thera-Band; Hygenic Corp.) and a chair (11\<RPE≤15 and 55\<70 HRmax).

Also known as: Telerehabilitation

Face-to-face physical therapy program (FPT Group); Synchronous telerehabilitation program (STR Group)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) both sexes aged ≥60 years, (ii) community-dwelling older adults, (iii) older adults having frailty according to the modified Fried phenotype scale, (iv) ability to stand up and walk ≥10 meters without assistance technique, (v) Abbreviated Mini Mental State (MMSE) \>13 points, (vi) no medical contraindication for physical exercise. In addition, older adults must have a smartphone or tablet, and Internet connection at home. Computer or Internet literacy is not required as an eligibility criterion.

Sponsors & Collaborators

• Marina Alvarado: lead

Study Sites (1)

Universidad Católica Silva Henríquez

Santiago, Santiago Metropolitan, 6513491, Chile

Location

Related Publications (14)

• Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.

  PMID: 31233135 BACKGROUND

• Neo JH, Teo ST, Lee CL, Cai CC. Telerehabilitation in the Treatment of Frozen Shoulder: A Case Report. Int J Telerehabil. 2019 Dec 12;11(2):3-8. doi: 10.5195/ijt.2019.6288. eCollection 2019.

  PMID: 35949924 BACKGROUND

• Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.

  PMID: 32386218 BACKGROUND

• 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.

  PMID: 32629502 BACKGROUND

• Changizi M, Kaveh MH. Effectiveness of the mHealth technology in improvement of healthy behaviors in an elderly population-a systematic review. Mhealth. 2017 Nov 27;3:51. doi: 10.21037/mhealth.2017.08.06. eCollection 2017.

  PMID: 29430455 BACKGROUND

• Wu G, Keyes LM. Group tele-exercise for improving balance in elders. Telemed J E Health. 2006 Oct;12(5):561-70. doi: 10.1089/tmj.2006.12.561.

  PMID: 17042710 BACKGROUND

• Solis-Navarro L, Gismero A, Fernandez-Jane C, Torres-Castro R, Sola-Madurell M, Berge C, Perez LM, Ars J, Martin-Borras C, Vilaro J, Sitja-Rabert M. Effectiveness of home-based exercise delivered by digital health in older adults: a systematic review and meta-analysis. Age Ageing. 2022 Nov 2;51(11):afac243. doi: 10.1093/ageing/afac243.

  PMID: 36346736 BACKGROUND

• Yuen J, Thiyagarajan CA, Belci M. Patient experience survey in telemedicine for spinal cord injury patients. Spinal Cord. 2015 Apr;53(4):320-3. doi: 10.1038/sc.2014.247. Epub 2015 Jan 27.

  PMID: 25622730 BACKGROUND

• Levy CE, Silverman E, Jia H, Geiss M, Omura D. Effects of physical therapy delivery via home video telerehabilitation on functional and health-related quality of life outcomes. J Rehabil Res Dev. 2015;52(3):361-70. doi: 10.1682/JRRD.2014.10.0239.

  PMID: 26230650 BACKGROUND

• Schmeler MR, Schein RM, McCue M, Betz K. Telerehabilitation clinical and vocational applications for assistive technology: research, opportunities, and challenges. Int J Telerehabil. 2009 Sep 4;1(1):59-72. doi: 10.5195/ijt.2009.6014. eCollection 2009 Fall.

  PMID: 25945163 BACKGROUND

• Irgens I, Rekand T, Arora M, Liu N, Marshall R, Biering-Sorensen F, Alexander M. Telehealth for people with spinal cord injury: a narrative review. Spinal Cord. 2018 Jul;56(7):643-655. doi: 10.1038/s41393-017-0033-3. Epub 2018 Mar 7.

  PMID: 29515211 BACKGROUND

• Theodoros D, Russell T. Telerehabilitation: current perspectives. Stud Health Technol Inform. 2008;131:191-209.

  PMID: 18431862 BACKGROUND

• Kairy D, Tousignant M, Leclerc N, Cote AM, Levasseur M, Researchers TT. The patient's perspective of in-home telerehabilitation physiotherapy services following total knee arthroplasty. Int J Environ Res Public Health. 2013 Aug 30;10(9):3998-4011. doi: 10.3390/ijerph10093998.

  PMID: 23999548 BACKGROUND

• Cigarroa I, Reyes-Molina D, Vargas-Rios F, Lopez-Alarcon G, Jara-Aceituno S, Riquelme-Hernandez C, Zapata-Lamana R, Parra-Rizo MA. Effectiveness of Synchronous Telerehabilitation Versus Face-to-Face Physical Therapy in Older Adults Who Are Frail: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 16;14:e72318. doi: 10.2196/72318.

  PMID: 40957013 DERIVED

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Igor Cigarroa, PhD

CONTACT

+56 9 5665 8927; icigarroac@ucsh.cl

Marina Alvarado, PhD

CONTACT

+56224601133; malvarado@usch.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study has been designed as a blinded (assessor and statistician), parallel group, randomized controlled trial (RCT)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: Synchronous telerehabilitation program (STR group) During the exercise session, the participants turns on the tablet PC, watches the instructor perform the exercise, and follows the instructor's movements. For the instructor to observe the correct movements of the participants, the resistance and balance exercises are performed in the frontal and sagittal planes. During each session, a technical stuff will supervise up to four or five participants exercising remotely at home, using a real-time videoconferencing app (Zoom®, CA, USA). The videoconference session will be projected on a television screen located in an older adult's care center. Once the technical stuff has been assigned participants, their supervision will not be interchangeable. Participants will be able to see and talk to both, the healthcare professional and other participants. The older adults, from their homes, will complete 1-hour sessions, twice a week for 12 weeks.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: April 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: August 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

CL (1)