Clinical trial NCT06388499: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions
Official title: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions: a Mixed-methods Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Conditions, Multiple
Keywords: telerehabilitation
physiotherapy
feasibility
exercise
chronic conditions
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment rate assessed by number of participants recruited during recruitment period.
timeFrame: 4 weeks
measure: Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments.
timeFrame: 8 weeks
measure: Adherence rate assessed by the attendance at synchronous group exercise sessions
timeFrame: 6 weeks
measure: Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8)
timeFrame: 6 weeks
measure: Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS)
timeFrame: 6 weeks
measure: Adverse events assessed via self-report questionnaire
timeFrame: 6 weeks
measure: Intervention acceptability as assessed by qualitative feedback from participants via focus groups
timeFrame: 6 weeks
Secondary outcomes:
measure: Physical function assessed by the 30-second chair stand test (30CST).
timeFrame: 6 weeks
measure: Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tipperary
country: Ireland
facility: South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir
Study officials:
affiliation: University of Limerick, Ireland
name: Roisin Cahalan, PhD
role: PRINCIPAL_INVESTIGATOR
References: