Chronic Conditions, MultipleNCT06388499
A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions
A study testing TECC (Telerehabilitation and Exercise for Chronic Conditions) in people with Chronic Conditions, Multiple, run by University of Limerick at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Conditions, Multiple
- What is being tested?
- TECC (Telerehabilitation and Exercise for Chronic Conditions)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 16 Apr 2024to 11 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir
Tipperary
About this study
Official title: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions: a Mixed-methods Feasibility Trial
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.
Read the 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
- Being tested
- TECC (Telerehabilitation and Exercise for Chronic Conditions)
- Keywords
- telerehabilitation, physiotherapy, feasibility, exercise, chronic conditions
- Medical subject headings
- Multiple Chronic Conditions, Motor Activity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: TECC (Telerehabilitation and Exercise for Chronic Conditions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate assessed by number of participants recruited during recruitment period.
The number of participants recruited over a 4-week recruitment period
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (2)
Physical function assessed by the 30-second chair stand test (30CST).
The 30-second chair stand test (30CST) will be administered both pre-intervention and post-intervention to assess the effect of the intervention on objective physical function.
Measured: 6 weeks
Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L).
The Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L) will be administered in pre-intervention and post-intervention assessments to assess the effect of the intervention on quality of life. The Euro-QoL-5D-5L is a patient-reported outcome measure which assesses health-related quality of life across five dimensions of health using a 5-point rating scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start16 Apr 2024
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Conditions, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RoisinCahalan, University of Limerick
- Investigators
- Roisin Cahalan, PhD, Principal investigator, University of Limerick, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388499
- Sponsor's protocol ID
- GOIPG/2022/1854
- Status last verified
- Dec 2024
- First submitted
- 19 Apr 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions: a Mixed-methods Feasibility Trial
- ClinicalTrials.gov ID
- NCT06388499
- Acronym / sponsor ID
- GOIPG/2022/1854
- Conditions
- Chronic Conditions, Multiple
- Keywords
- telerehabilitation, physiotherapy, feasibility, exercise, chronic conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TECC intervention group | Experimental | Other: TECC (Telerehabilitation and Exercise for Chronic Conditions)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | TECC intervention group |
Primary outcome
Recruitment rate assessed by number of participants recruited during recruitment period.
Time frame: 4 weeks
The number of participants recruited over a 4-week recruitment period
Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments.
Time frame: 8 weeks
The percentage of enrolled participants who complete the post-intervention assessments and focus groups
Adherence rate assessed by the attendance at synchronous group exercise sessions
Time frame: 6 weeks
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.
Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8)
Time frame: 6 weeks
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
Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS)
Time frame: 6 weeks
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).
Adverse events assessed via self-report questionnaire
Time frame: 6 weeks
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.
Intervention acceptability as assessed by qualitative feedback from participants via focus groups
Time frame: 6 weeks
Qualitative semi-structured focus groups will be carried out to collect data regarding patient experiences and acceptability of the intervention.
2 secondary outcomes
Physical function assessed by the 30-second chair stand test (30CST).
Time frame: 6 weeks
Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L).
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Related trials for Chronic Conditions, Multiple
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
RecruitingPhase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyneuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roisin Cahalan, PhD principal investigator
University of Limerick, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECC (Telerehabilitation and Exercise for Chronic Conditions) in people with Chronic Conditions, Multiple, run by University of Limerick at 1 site in Ireland.
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 3 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 Dec 2024. 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 Ireland. 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 assessed by number of participants recruited during recruitment period. (time frame: 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.