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

NCT06388499 | Completed

• 1 other identifier: GOIPG/2022/1854
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Conditions, Multiple

Keywords

telerehabilitation; physiotherapy; feasibility; exercise; chronic conditions

Outcome Measures

Primary Outcomes (7)

• Recruitment rate assessed by number of participants recruited during recruitment period.

  The number of participants recruited over a 4-week recruitment period

  4 weeks

• Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments.

  The percentage of enrolled participants who complete the post-intervention assessments and focus groups

  8 weeks

• Adherence rate assessed by the attendance at synchronous group exercise sessions

  Adherence with the overall intervention will be recorded by the attendance of participants at the synchronous group exercise sessions throughout the 6-week intervention period which will be recorded by the researchers.

  6 weeks

• Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8)

  Satisfaction with the overall intervention will be examined using the Client-Satisfaction Questionnaire 8 (CSQ-8). The CSQ-8 scale is an 8-item scale which rates satisfaction on a 4-point Likert scale. An overall score is calculated by summing the respondent's rating score for each scale item with totals ranging from 8 to 32, with higher values indicating higher satisfaction

  6 weeks

• Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS)

  Participant satisfaction with individual components of the intervention (including the orientation session, exercise sessions, educational webinars, and social components) will be assessed using Numerical Rating Scales (NRS).

  6 weeks

• Adverse events assessed via self-report questionnaire

  Participants will be asked during the post-intervention assessment to report the occurrence of any adverse events during the intervention period via a custom questionnaire. Adverse events will be defined as any problems or injuries experienced during the study that is deemed by the participant to be more likely resulting from participation in the intervention, rather than resulting from disease progression. Serious adverse events will be defined as any medical occurrence resulting in death, threat to life, hospital admission or significant disability.

  6 weeks

• Intervention acceptability as assessed by qualitative feedback from participants via focus groups

  Qualitative semi-structured focus groups will be carried out to collect data regarding patient experiences and acceptability of the intervention.

  6 weeks

Secondary Outcomes (2)

• Physical function assessed by the 30-second chair stand test (30CST).

  6 weeks

• Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L).

  6 weeks

Study Arms (1)

TECC intervention group

EXPERIMENTAL

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.

Other: TECC (Telerehabilitation and Exercise for Chronic Conditions)

Interventions

TECC (Telerehabilitation and Exercise for Chronic Conditions) 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.

TECC intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

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

Tipperary, Ireland

Location

MeSH Terms

Conditions

Multiple Chronic Conditions; Motor Activity; Chronic Disease

Interventions

Telerehabilitation; Exercise

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

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; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Roisin Cahalan, PhD

  University of Limerick, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 29, 2024
• Study Start: April 16, 2024
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

IE (1)