A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions

NCT ID: NCT06388499

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2024-07-11

Brief Summary

This protocol outlines a planned mixed methods feasibility trial which will be conducted to examine the feasibility and acceptability of a physiotherapy-led exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions.

Detailed Description

Evidence supports the efficacy of exercise-based group rehabilitation programmes for people with chronic conditions. Telerehabilitation, referring to the remote delivery of rehabilitation using telecommunication technology, has the potential to increase service accessibility, uptake, and adherence to rehabilitation programmes. Telerehabilitation research has previously evaluated condition-specific programmes, such as cardiac telerehabilitation programmes delivered specifically to cardiac populations. However, recent evidence examining traditional in-person rehabilitation programmes points to the potential of rehabilitation programmes for mixed-condition patient groups as an efficient and pragmatic alternative approach to rehabilitation service delivery. The proposed study aims to examine the feasibility and acceptability of an exercise-based telerehabilitation programme delivered to groups of people with a mixture of different chronic conditions.

A mixed methods feasibility trial will be conducted to examine the feasibility of an exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions. The 6-week intervention will involve exercise, educational, and social components. The intervention will include two different exercise group levels, one conducting a seat-based exercise class and the other a standing-based exercise class. Participants will take part in one synchronous group exercise session per week delivered via videoconferencing. This session will be followed by the opportunity to engage in a guided social discussion with peers via the videoconferencing platform. The social component of the intervention will be loosely structured and aims to provide a social dimension to the intervention, which has been previously identified by stakeholders as an important component of telerehabilitation programmes. The social discussion will be driven by patient preference and may refer to clinical issues such as supports or issues related to chronic conditions, or non-clinical issues related to current news/events. Participants will be provided access to a synchronous online self-management educational webinar each week also delivered via videoconferencing. Access to recordings of the exercise classes and educational webinars will also be provided to allow participants to engage with the sessions at their convenience during the intervention period. Data will be collected and analysed to address outcomes of feasibility and acceptability including recruitment, retention, intervention adherence including adherence with synchronous exercise and education sessions and with recorded exercise and education content, participant satisfaction, safety, participant experiences and clinical effectiveness of the intervention.

The proposed feasibility trial will guide new iterations and evaluation and potentially a future definitive randomised control trial evaluating the use of exercise-based telerehabilitation interventions for groups of people with mixed chronic health conditions. The proposed intervention has been designed with the aim of developing a sustainable, cost-effective, and efficacious healthcare delivery method to tackle the increasing demand for rehabilitation programmes for people with chronic health conditions.

Conditions

Chronic Conditions, Multiple

Keywords

telerehabilitation; physiotherapy; feasibility; exercise; chronic conditions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TECC intervention group

The intervention will comprise of a 6-week disease-agnostic exercise-based telerehabilitation programme for people with chronic health conditions delivered by a chartered physiotherapist. The intervention will consist of weekly synchronous exercise sessions and guided social component, and synchronous educational webinars to promote self-management of health and well-being. The intervention will be delivered remotely via telehealth. The intervention will include two exercise level groups (one seated class group conducting exercises in sitting, the other standing class conducting exercises in a range of standing/dynamic/functional positions). Allocation to the appropriate exercise level will be based on participants' baseline functional mobility level which will be assessed using the Activities-specific Balance Confidence (ABC) Scale.

Group Type: EXPERIMENTAL

TECC (Telerehabilitation and Exercise for Chronic Conditions)

Intervention Type: OTHER

Exercise: Synchronous group exercise sessions will be delivered weekly via videoconferencing by a physiotherapist. Recordings of exercise sessions will be made available. Participants will be advised to perform additional exercise sessions at their own convenience to supplement the synchronous exercise sessions and facilitate adherence to physical activity guidelines.

Education: A synchronous educational webinar will be delivered each week. These will be delivered by relevant healthcare professionals and explore various aspects of self-management of health and well-being. Recordings of the webinars will be made available to participants.

Social component: At the end of each weekly synchronous group exercise session, participants will have the opportunity to engage in a 10-15-minute synchronous online social interaction with other participants in their exercise group via videoconferencing.

Interventions

TECC (Telerehabilitation and Exercise for Chronic Conditions)

Exercise: Synchronous group exercise sessions will be delivered weekly via videoconferencing by a physiotherapist. Recordings of exercise sessions will be made available. Participants will be advised to perform additional exercise sessions at their own convenience to supplement the synchronous exercise sessions and facilitate adherence to physical activity guidelines.

Education: A synchronous educational webinar will be delivered each week. These will be delivered by relevant healthcare professionals and explore various aspects of self-management of health and well-being. Recordings of the webinars will be made available to participants.

Social component: At the end of each weekly synchronous group exercise session, participants will have the opportunity to engage in a 10-15-minute synchronous online social interaction with other participants in their exercise group via videoconferencing.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Community-dwelling adults (aged ≥18 years old) with a confirmed diagnosis of any chronic cardiorespiratory, neurological, or musculoskeletal condition. We will use the ICD-10-CM definition of a chronic condition being one lasting greater than 12 months and resulting in the need for ongoing medical intervention and limiting self-care, independent living, and social interaction.
• Person is medically stable and appropriate to participate in the exercise-based intervention independently and safely as deemed by self-declaration. Participants who fulfil the criteria will undergo screening by the research team to gather relevant medical history and will be required complete the Physical Activity Readiness Questionnaire (PAR-Q) form. If any concerns arise from the PAR-Q form, participants will be advised to discuss their suitability for participation in the intervention with their GP in advance of signing the disclaimer prior to participation. Participants will be required to sign a disclaimer to agree voluntary participation in the exercise intervention at their own risk prior to participating.
• Access to an appropriate technological device with an internet connection and email address to facilitate participation in the telerehabilitation intervention.
• Willing to provide informed consent to participate in the study.
• Good level of spoken and written English.

Exclusion Criteria

• Adults who are medically unstable as deemed by referring physiotherapist or who have uncontrolled medical conditions limiting participation in exercise interventions including uncontrolled hypertension or recent acute cardiovascular events, uncontrolled atrial fibrillation, etc.
• Significant orthopaedic, psychological, neurological, or cognitive conditions or mobility difficulties that prevents participation in seated or standing exercise interventions as deemed by referring physiotherapist.
• Suspected underlying malignancy as deemed by referring physiotherapist.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Limerick

OTHER

Sponsor Role: lead

Responsible Party

RoisinCahalan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roisin Cahalan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Limerick, Ireland

Locations

South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir

Tipperary, , Ireland

Countries

Ireland

Other Identifiers

GOIPG/2022/1854

Identifier Type: -

Identifier Source: org_study_id