Chronic Musculoskeletal PainComEx PainNCT06535633
Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain
A study testing Intervention arm: Exercise class in people with Chronic Musculoskeletal Pain, run by University of Limerick at 1 site in Ireland.
Trial summary
Chronic pain management services in Ireland are severely under-resourced. There is a key opportunity for community-based exercise to address some of the needs of people early in their chronic pain journey and potentially prevent or reduce their needs for secondary healthcare support, reducing the burden on healthcare… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Intervention arm: Exercise class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be aged 50 or older,
- report chronic MSK pain of ≥3 months duration,
- not currently meeting the exercise guidelines of 150 minutes of moderate physical activity per week (determined using the International Physical Activity Questionnaire (IPAQ)
Who cannot join
- Participants will be excluded if they have health conditions which could be worsened by exercise (e.g. neurological, or cardiovascular conditions, post-exertional malaise (screened using the DePaul Post-Exertional Malaise Questionnaire have recently undergone trauma or surgery, or have significant mobility issues which would limit exercise participation.
- Participants who are unable to communicate in English sufficiently to complete consent or baseline assessment will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
University of Limerick, Ireland
Limerick, V94 TPPX
About this study
Official title: Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain: a Randomised Controlled Feasibility Trial
Chronic pain management services in Ireland are severely under-resourced. There is a key opportunity for community-based exercise to address some of the needs of people early in their chronic pain journey and potentially prevent or reduce their needs for secondary healthcare support, reducing the burden on healthcare waiting lists.
Musculoskeletal pain is a significant barrier to participation in physical activity for these older adults, and at present, community-based exercise trainers do not have any education or resources to help support people with chronic pain to sustain their participation in physical activity programmes. Healthcare professionals who hold negative beliefs in relation to the role of physical activity for chronic pain are more likely to provide advice that reinforces unhelpful behaviours and increases disability. Pain education has been shown to positively change beliefs and shift views towards more evidence-based physical activity recommendations in a range of professionals including physiotherapists, nurses and sports therapists. In addition, specific psychological and behavioural approaches to support self-efficacy, develop pacing skills, and manage pain flareups are required to help people with chronic pain sustain their engagement in exercise. Appropriate education is required to equip those working with people in chronic pain to facilitate these skills. While exercise is a safe intervention, there are key differences in how people with chronic pain may respond to or recover from exercise that need to be planned for in exercise programmes. People with chronic pain vary greatly in their abilities and functional limitations, goals, and lifestyle, in comparison to those without troublesome pain. A review of qualitative data from people with fibromyalgia showed that they report self-selecting an exercise intensity lower than the guideline recommended level to avoid adverse effects and build pain management skills. Patient-public involvement (PPI) focus groups and a survey conducted in the development of this protocol showed that people with chronic pain were very reluctant to enrol in current community-based physical activity opportunities due to anxiety that the exercise leader would not understand or be able to meet their specific needs, and the consequent fear of symptom exacerbation. The most important priority identified for their participation was having an exercise leader who was trained in supporting people with pain. Exercise that is tailored to the specific needs of people with pain is likely to offer a more supportive, safe, and effective approach. There is a clear need for a project developing and delivering an educational intervention for exercise trainers, to support people with pain to exercise in their community.
Read the detailed description
The investigators have trained exercise trainers in Pain neuroscience and they will lead a set of classes, adapted to the needs of people with chronic pain. In addition, the investigators have conducted PPI activities with the members of Chronic Pain Ireland, to understand the barriers and facilitators for community-based exercise and their needs in relation to same. A survey of (n=130) members of CPI highlighted key barriers to community-based exercise included fear of pain exacerbation, and not having a skilled exercise leader. Access to an exercise trainer trained in supporting people with chronic pain was the top facilitator of engagement with exercise chosen by respondents. Focus groups with people with chronic pain detailed the important factors to consider in planning an exercise intervention, these being that the activity should be enjoyable, non-competitive and accessible to all levels of physical activity, and the venues should offer easy access with public transport. Based on this data and framed within the biopsychosocial model of chronic pain (Figure 1), a number of exercise types from the current LSP offerings that could meet the needs of people with chronic MSK pain, namely Tai Chi, Activator Pole walking and Aquarobics were identified. These classes run once a week for 8 weeks. The intervention group will also receive a paper-based education manual about physical activity and pain management education designed for people with chronic pain and based on the "Explain Pain" principles.
The control group comprises the same paper-based education manual about physical activity and pain management education designed for people with chronic pain and based on the "Explain Pain" principles. These participants will continue with usual care for their chronic pain. Based on PPI feedback suggesting the importance of equity for all who volunteer to take part, those in the control group will be offered the opportunity to participate in the intervention (group exercise classes) after they have completed their final follow up assessments.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Intervention arm: Exercise class
- Keywords
- chronic musculoskeletal pain,, exercise, feasibility
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: Exercise classOther
The exercise trainers, who are educated in chronic pain, will lead a set of classes, adapted to the needs of people with chronic pain. The investigators have conducted PPI activities with the members of Chronic Pain Ireland, to understand the barriers and facilitators for community-based exercise and their needs in relation to same. A forthcoming publication reports the results of a survey of a survey of (n=130) members of CPI highlightinged that key barriers to community-based exercise included fear of pain exacerbation, and not having skilled exercise instruction. The exercise modalities of choice have been informed by the survey results as well as alignment with the LSP class offerings and trainer competency. Classes on offer are focused on aquatic exercise, Activator pole walking, yoga or Pilates, and circuit-style fitness, for participants to choose their own preferred option. Classes will run weekly for 8 weeks, duration 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: Exercise classes | Experimental | The investigators have trained exercise trainers in Pain neuroscience and they will lead a set of classes, adapted to the needs of people with chronic pain. Focus groups with people with chronic pain detailed the important factors to consider in planning an exercise intervention, these being that the activity should be enjoyable, non-competitive and accessible to all levels of physical activity, and the venues should offer easy access with public transport. The investigators have identified three exercise types from the current LSP offerings that could meet the needs of people with chronic MSK pain, namely Tai Chi, Activator Pole walking and Aquarobics, which will run once a week for 8 weeks. The intervention group will also receive a paper-based education manual about physical activity and pain management education designed for people with chronic pain. Receives: Other: Intervention arm: Exercise class |
| Control | No intervention | The control group comprises the same paper-based education manual about physical activity and pain management education designed for people with chronic pain and based on the "Explain Pain" principles. These participants will continue with usual care for their chronic pain. Based on PPI feedback suggesting the importance of equity for all who volunteer to take part, those in the control group will be offered the opportunity to participate in the intervention (group exercise classes) after they have completed their final follow up assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Overall numbers recruited per month during the recruitment phases
Measured: 2 month periods
Retention rate
Retention will be defined as the proportion of participants who complete baseline and post intervention measures.
Measured: End of intervention 8 weeks post baseline assessment
Refusal rate
- Refusal rate will be recorded as the number of eligible individuals who are invited to partake in the study but refuse to do so, with reasons recorded
Measured: 2 month periods of recruitment
Attendance rates at classes
- Attendance rates at classes will be reported as mean % attendance rates at classes, as well as the proportion of participants attending a minimum of 60% of classes (via attendance log taken at exercise classes) as the minimum acceptable attendance level.
Measured: each class for eight weeks
Secondary outcomes (14)
Pain Numerical Rating Scale for average pain intensity
Pain intensity will be measured as average pain for the previous week, using a 0-10 Numerical Rating Scale (NRS). The NRS has been shown to have acceptable reliability and validity in a range of chronic pain population
Measured: Baseline
Pain Numerical Rating Scale for average pain intensity
Pain intensity will be measured as average pain for the previous week, using a 0-10 Numerical Rating Scale (NRS). The NRS has been shown to have acceptable reliability and validity in a range of chronic pain population
Measured: End of intervention and corresponding control period: 8 weeks
Function via The Pain Disability Index (PDI)
The Pain Disability Index (PDI) is a 7-item questionnaire to investigate the magnitude of self-reported pain-related disability, independent from region of pain or pain-related diagnosis. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities. It has been widely validated in populations with chronic musculoskeletal pain
Measured: Baseline
Function via The Pain Disability Index (PDI)
The Pain Disability Index (PDI) is a 7-item questionnaire to investigate the magnitude of self-reported pain-related disability, independent from region of pain or pain-related diagnosis. The items of the questionnaire are assessed on a 0-10 numeric rating scale in which 0 means no disability and 10 is maximum disability. The sum of the seven items equals the total score of the PDI, which ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities. It has been widely validated in populations with chronic musculoskeletal pain
Measured: End of intervention and corresponding control period: 8 weeks
Emotional function: Hospital Anxiety and Depression Scale (HADS)
Emotional function: Hospital Anxiety and Depression Scale The HADS was originally a 14-item questionnaire to assess levels of depression and anxiety in hospital patients. It has been widely used in chronic pain research, but a recent factor analysis involving over 2500 people with chronic MSK pain showed that an 11-item version was a more valid and reliable measure of emotional distress related to pain than the full instrument, therefore the 11-item version will be used in the feasibility study. The results suggested that an 11-item refined version of the HADS could be considered as a unidimensional scale and, if implemented, could be suitable for the measurement of emotional distress in this population.
Minimum value: 0, maximum value: 11. Higher value indicates greater emotional distress
Measured: Baseline
Emotional function: Hospital Anxiety and Depression Scale (HADS)
The HADS was originally a 14-item questionnaire to assess levels of depression and anxiety in hospital patients. It has been widely used in chronic pain research, but a recent factor analysis involving over 2500 people with chronic MSK pain showed that an 11-item version was a more valid and reliable measure of emotional distress related to pain than the full instrument, therefore the 11-item version will be used in the feasibility study.
Minimum value: 0, maximum value: 11. Higher value indicates greater emotional distress
Measured: End of intervention and corresponding control period: 8 weeks
Rating of satisfaction/improvement
Rating overall improvement has been recommended as a core outcome in chronic pain, therefore a Global Rating of Change score is included, designed to quantify a participant's improvement or deterioration over time (Bobos et al. 2020). This is a 7 numbered scale balanced in the centre with "unchanged", and anchored with "very much worse" on the left, and "completely recovered" on the right" and the following prompt: With respect to your pain problem, how would you describe yourself now compared to when you began the study?.
The patient responds to the question by marking a scale that measures the degree of improvement or deterioration. The midpoint is important so that the patient is not forced to rate himself or herself as better or worse in the event that the condition has remained the same.
Minimum value: 1, maximum value:7, greater scores indicate a positive satisfaction response
Measured: Baseline
Rating of satisfaction/improvement
Rating overall improvement has been recommended as a core outcome in chronic pain, therefore a Global Rating of Change score, designed to quantify a participant's improvement or deterioration over time, will be used. This is a 7 numbered scale balanced in the centre with "unchanged", and anchored with "very much worse" on the left, and "completely recovered" on the right" and the following prompt: With respect to your pain problem, how would you describe yourself now compared to when you began the study? The patient responds to the question by marking a scale that measures the degree of improvement or deterioration. The midpoint is important so that the patient is not forced to rate himself or herself as better or worse in the event that the condition has remained the same.
Minimum value: 1, maximum value:7, greater scores indicate a positive satisfaction response
Measured: End of intervention and corresponding control period: 8 weeks
Physical activity objective via accelerometry
ActivPAL : Time spent in sedentary and non sedentary activity will be measured using the ActivPAL™ (PAL Technologies Ltd, Glasgow, UK). The ActivPAL™ is a small, lightweight activity monitor that classifies an individual's free-living activity into time periods spent in sedentary, standing and walking positions using proprietary algorithms.
The ActivPAL™ is a uni-axial accelerometer which produces a signal related to thigh inclination. The ActivPAL™ also records step count, i.e. number of steps taken, and transition count, i.e. number of movements from lying/sitting positions to standing and vice versa. The ActivPAL™ will be worn for 7 days at baseline and 7 days after the completion of the exercise intervention.
Measured: 7 days at baseline
Physical activity objective
ActivPAL ActivPAL : Time spent in sedentary and non sedentary activity will be measured using the ActivPAL™ (PAL Technologies Ltd, Glasgow, UK). The ActivPAL™ is a small, lightweight activity monitor that classifies an individual's free-living activity into time periods spent in sedentary, standing and walking positions using proprietary algorithms.
The ActivPAL™ is a uni-axial accelerometer which produces a signal related to thigh inclination. The ActivPAL™ also records step count, i.e. number of steps taken, and transition count, i.e. number of movements from lying/sitting positions to standing and vice versa. The ActivPAL™ will be worn for 7 days at baseline and 7 days after the completion of the exercise intervention.
Measured: 7 days after completion of the exercise intervention
Physical activity subjective via International Physical Activity Questionnaire
International Physical Activity Questionnaire (IPAQ) which measures duration and frequency of physical activity over the preceding 7 days across a range of domains including leisure time, domestic and gardening activities, work-related and transport-related activity, and has been shown to be reliable in populations with chronic MSK conditions.
Scoring categories:
Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.
Scoring a MODERATE level of physical activity on the IPAQ means you are doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.
Scoring a LOW level of physical activity on the IPAQ means that you are not meeting any of the criteria for either MODERATE of HIGH levels of physical activity.
Measured: Baseline
Physical activity subjective via International Physical Activity Questionnaire
International Physical Activity Questionnaire (IPAQ) which measures duration and frequency of physical activity over the preceding 7 days across a range of domains including leisure time, domestic and gardening activities, work-related and transport-related activity, and has been shown to be reliable in populations with chronic MSK conditions.
Scoring categories:
Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.
Scoring a MODERATE level of physical activity on the IPAQ means you are doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days.
Scoring a LOW level of physical activity on the IPAQ means that you are not meeting any of the criteria for either MODERATE of HIGH levels of physical activity.
Measured: End of intervention and corresponding control period: 8 weeks
Health-related quality of life via EQ-5d-5l,( EuroQol)
The EQ-5d-5l, a valid and response measure of health-related quality of life, covering five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension in the descriptive system has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: Baseline
Health-related quality of life
The EQ-5d-5l, a valid and response measure of health-related quality of life, covering five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension in the descriptive system has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: End of intervention and corresponding control period: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen McCreesh, PhD, Principal investigator, UL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535633
- Sponsor's protocol ID
- 2024_02_23_EHS
- Other IDs
- DIFA-2-23-024, 7272
- Acronym
- ComEx Pain
- Status last verified
- Dec 2024
- First submitted
- 30 Jul 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study and will be available upon request from Dr Mairéad Conneely, mairead.c.conneely@ul.ie
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
- Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain: a Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06535633
- Acronym / sponsor ID
- ComEx Pain / 2024_02_23_EHS
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- chronic musculoskeletal pain,, exercise, feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 2 Aug 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.
Chronic pain management services in Ireland are severely under-resourced. There is a key opportunity for community-based exercise to address some of the needs of people early in their chronic pain journey and potentially prevent or reduce their needs for secondary healthcare support, reducing the burden on healthcare waiting lists.
Musculoskeletal pain is a significant barrier to participation in physical activity for these older adults, and at present, community-based exercise trainers do not have any education or resources to help support people with chronic pain to sustain their participation in physical activity programmes. Healthcare professionals who hold negative beliefs in relation to the role of physical activity for chronic pain are more likely to provide advice that reinforces unhelpful behaviours and increases disability. Pain education has been shown to positively change beliefs and shift views towards more evidence-based physical activity recommendations in a range of professionals including physiotherapists, nurses and sports therapists. In addition, specific psychological and behavioural approaches to support self-efficacy, develop pacing skills, and manage pain flareups are required to help people with chronic pain sustain their engagement in exercise. Appropriate education is required to equip those working with people in chronic pain to facilitate these skills. While exercise is a safe intervention, there are key differences in how people with chronic pain may respond to or recover from exercise that need to be planned for in exercise programmes. People with chronic pain vary greatly in their abilities and functional limitations, goals, and lifestyle, in comparison to those without troublesome pain. A review of qualitative data from people with fibromyalgia showed that they report self-selecting an exercise intensity lower than the guideline recommended level to avoid adverse effects and build pain management skills. Patient-public involvement (PPI) focus groups and a survey conducted in the development of this protocol showed that people with chronic pain were very reluctant to enrol in current community-based physical activity opportunities due to anxiety that the exercise leader would not understand or be able to meet their specific needs, and the consequent fear of symptom exacerbation. The most important priority identified for their participation was having an exercise leader who was trained in supporting people with pain. Exercise that is tailored to the specific needs of people with pain is likely to offer a more supportive, safe, and effective approach. There is a clear need for a project developing and delivering an educational intervention for exercise trainers, to support people with pain to exercise in their community.
Detailed description
The investigators have trained exercise trainers in Pain neuroscience and they will lead a set of classes, adapted to the needs of people with chronic pain. In addition, the investigators have conducted PPI activities with the members of Chronic Pain Ireland, to understand the barriers and facilitators for community-based exercise and their needs in relation to same. A survey of (n=130) members of CPI highlighted key barriers to community-based exercise included fear of pain exacerbation, and not having a skilled exercise leader. Access to an exercise trainer trained in supporting people with chronic pain was the top facilitator of engagement with exercise chosen by respondents. Focus groups with people with chronic pain detailed the important factors to consider in planning an exercise intervention, these being that the activity should be enjoyable, non-competitive and accessible to all levels of physical activity, and the venues should offer easy access with public transport. Based on this data and framed within the biopsychosocial model of chronic pain (Figure 1), a number of exercise types from the current LSP offerings that could meet the needs of people with chronic MSK pain, namely Tai Chi, Activator Pole walking and Aquarobics were identified. These classes run once a week for 8 weeks. The intervention group will also receive a paper-based education manual about physical activity and pain management education designed for people with chronic pain and based on the "Explain Pain" principles.
The control group comprises the same paper-based education manual about physical activity and pain management education designed for people with chronic pain and based on the "Explain Pain" principles. These participants will continue with usual care for their chronic pain. Based on PPI feedback suggesting the importance of equity for all who volunteer to take part, those in the control group will be offered the opportunity to participate in the intervention (group exercise classes) after they have completed their final follow up assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: Exercise classes | Experimental | Other: Intervention arm: Exercise classThe investigators have trained exercise trainers in Pain neuroscience and they will lead a set of classes, adapted to the needs of people with chronic pain. Focus groups with people with chronic pain detailed the important factors to consider in planning an exercise intervention, these being that the activity should be enjoyable, non-competitive and accessible to all levels of physical activity, and the venues should offer easy access with public transport. The investigators have identified three exercise types from the current LSP offerings that could meet the needs of people with chronic MSK pain, namely Tai Chi, Activator Pole walking and Aquarobics, which will run once a week for 8 weeks. The intervention group will also receive a paper-based education manual about physical activity and pain management education designed for people with chronic pain. |
| Control | No intervention | –The control group comprises the same paper-based education manual about physical activity and pain management education designed for people with chronic pain and based on the "Explain Pain" principles. These participants will continue with usual care for their chronic pain. Based on PPI feedback suggesting the importance of equity for all who volunteer to take part, those in the control group will be offered the opportunity to participate in the intervention (group exercise classes) after they have completed their final follow up assessments. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be aged 50 or older,
- report chronic MSK pain of ≥3 months duration,
- not currently meeting the exercise guidelines of 150 minutes of moderate physical activity per week (determined using the International Physical Activity Questionnaire (IPAQ)
Key exclusion criteria (2 listed)
- Participants will be excluded if they have health conditions which could be worsened by exercise (e.g. neurological, or cardiovascular conditions, post-exertional malaise (screened using the DePaul Post-Exertional Malaise Questionnaire have recently undergone trauma or surgery, or have significant mobility issues which would limit exercise participation.
- Participants who are unable to communicate in English sufficiently to complete consent or baseline assessment will be excluded
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 |
|---|---|---|
| Intervention arm: Exercise classThe exercise trainers, who are educated in chronic pain, will lead a set of classes, adapted to the needs of people with chronic pain. The investigators have conducted PPI activities with the members of Chronic Pain Ireland, to understand the barriers and facilitators for community-based exercise and their needs in relation to same. A forthcoming publication reports the results of a survey of a survey of (n=130) members of CPI highlightinged that key barriers to community-based exercise included fear of pain exacerbation, and not having skilled exercise instruction. The exercise modalities of choice have been informed by the survey results as well as alignment with the LSP class offerings and trainer competency. Classes on offer are focused on aquatic exercise, Activator pole walking, yoga or Pilates, and circuit-style fitness, for participants to choose their own preferred option. Classes will run weekly for 8 weeks, duration 1 hour. | Other | Intervention arm: Exercise classes |
Primary outcome
Recruitment rate
Time frame: 2 month periods
Overall numbers recruited per month during the recruitment phases
Retention rate
Time frame: End of intervention 8 weeks post baseline assessment
Retention will be defined as the proportion of participants who complete baseline and post intervention measures.
Refusal rate
Time frame: 2 month periods of recruitment
• Refusal rate will be recorded as the number of eligible individuals who are invited to partake in the study but refuse to do so, with reasons recorded
Attendance rates at classes
Time frame: each class for eight weeks
• Attendance rates at classes will be reported as mean % attendance rates at classes, as well as the proportion of participants attending a minimum of 60% of classes (via attendance log taken at exercise classes) as the minimum acceptable attendance level.
14 secondary outcomes
Pain Numerical Rating Scale for average pain intensity
Time frame: Baseline
Pain Numerical Rating Scale for average pain intensity
Time frame: End of intervention and corresponding control period: 8 weeks
Function via The Pain Disability Index (PDI)
Time frame: Baseline
Function via The Pain Disability Index (PDI)
Time frame: End of intervention and corresponding control period: 8 weeks
Emotional function: Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Emotional function: Hospital Anxiety and Depression Scale (HADS)
Time frame: End of intervention and corresponding control period: 8 weeks
Rating of satisfaction/improvement
Time frame: Baseline
Rating of satisfaction/improvement
Time frame: End of intervention and corresponding control period: 8 weeks
Physical activity objective via accelerometry
Time frame: 7 days at baseline
Physical activity objective
Time frame: 7 days after completion of the exercise intervention
Physical activity subjective via International Physical Activity Questionnaire
Time frame: Baseline
Physical activity subjective via International Physical Activity Questionnaire
Time frame: End of intervention and corresponding control period: 8 weeks
Health-related quality of life via EQ-5d-5l,( EuroQol)
Time frame: Baseline
Health-related quality of life
Time frame: End of intervention and corresponding control period: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study and will be available upon request from Dr Mairéad Conneely, mairead.c.conneely@ul.ie
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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.
Karen McCreesh, PhD principal investigator
UL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: Exercise class in people with Chronic Musculoskeletal Pain, 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 3 inclusion and 2 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen McCreesh, PhD (00353 61 234233, karen.mccreesh@ul.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 2 month periods). The study lists 4 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.