Clinical trial NCT06535633: Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain
Official title: Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain: a Randomised Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: chronic musculoskeletal pain,
exercise
feasibility
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 2 month periods
measure: Retention rate
timeFrame: End of intervention 8 weeks post baseline assessment
measure: Refusal rate
timeFrame: 2 month periods of recruitment
measure: Attendance rates at classes
timeFrame: each class for eight weeks
Secondary outcomes:
measure: Pain Numerical Rating Scale for average pain intensity
timeFrame: Baseline
measure: Pain Numerical Rating Scale for average pain intensity
timeFrame: End of intervention and corresponding control period: 8 weeks
measure: Function via The Pain Disability Index (PDI)
timeFrame: Baseline
measure: Function via The Pain Disability Index (PDI)
timeFrame: End of intervention and corresponding control period: 8 weeks
measure: Emotional function: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Emotional function: Hospital Anxiety and Depression Scale (HADS)
timeFrame: End of intervention and corresponding control period: 8 weeks
measure: Rating of satisfaction/improvement
timeFrame: Baseline
measure: Rating of satisfaction/improvement
timeFrame: End of intervention and corresponding control period: 8 weeks
measure: Physical activity objective via accelerometry
timeFrame: 7 days at baseline
measure: Physical activity objective
timeFrame: 7 days after completion of the exercise intervention
measure: Physical activity subjective via International Physical Activity Questionnaire
timeFrame: Baseline
measure: Physical activity subjective via International Physical Activity Questionnaire
timeFrame: End of intervention and corresponding control period: 8 weeks
measure: Health-related quality of life via EQ-5d-5l,( EuroQol)
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: End of intervention and corresponding control period: 8 weeks
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick, Ireland
Study officials:
affiliation: UL
name: Karen McCreesh, PhD
role: PRINCIPAL_INVESTIGATOR
References: