Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain

NCT06535633 | Recruiting DMC

• 2 other identifiers: 2024_02_23_EHSDIFA-2-23-024, 7272
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

chronic musculoskeletal pain,; exercise; feasibility

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Overall numbers recruited per month during the recruitment phases

  2 month periods

• Retention rate

  Retention will be defined as the proportion of participants who complete baseline and post intervention measures.

  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

  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.

  each class for eight weeks

Secondary Outcomes (14)

• Pain Numerical Rating Scale for average pain intensity

  Baseline

• Pain Numerical Rating Scale for average pain intensity

  End of intervention and corresponding control period: 8 weeks

• Function via The Pain Disability Index (PDI)

  Baseline

• Function via The Pain Disability Index (PDI)

  End of intervention and corresponding control period: 8 weeks

• Emotional function: Hospital Anxiety and Depression Scale (HADS)

  Baseline

Study Arms (2)

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.

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.

Interventions

Intervention arm: Exercise class OTHER

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.

Intervention arm: Exercise classes

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University of Limerick, Ireland

Limerick, V94 TPPX, Ireland

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Karen McCreesh, PhD

  UL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen McCreesh, PhD

CONTACT

00353 61 234233; karen.mccreesh@ul.ie

Mairead Conneely, PhD

CONTACT

00353 61 234233; mairead.c.conneely@ul.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Once the protocol is published, it will be shared and available on the published platform.
• Access Criteria: Open access

Locations

IE (1)