Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535633
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain a Randomised Controlled Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ComEx Pain
Brief 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 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
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 n130 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None