Community-based Exercise for Older Adults With Chronic Musculoskeletal Pain
NCT Number: NCT06535633
Acronym: ComEx Pain
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Musculoskeletal Pain
Interventions: OTHER: Intervention arm: Exercise class
Sponsor: University of Limerick
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2025-11-01

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.

Primary Outcome Measures: 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 Outcome Measures: 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, 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, 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, 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, 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, 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, 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, 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, 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., 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., 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., 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., 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., 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., End of intervention and corresponding control period: 8 weeks