Clinical trial NCT05091671: Free From Pain Exercise Programme Study
Official title: Investigating the Effectiveness of the "Free From Pain" Exercise and Education Programme in Decreasing Early Osteoarthritic / Generalised Musculoskeletal Pain in People Over 60 Years of Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Pain
Fear of Falling
Lead sponsor: Talita Cumi Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of the "Free from Pain" exercise and information programme. The complete programme provides exercises and information for people over the age of 60 to reduce early osteoarthritic and generalised musculoskeletal pain and fear of falling. The study will compare the effects of 2 versions of the Free from Pain programme to ascertain which is the most effective.

Detailed description: Chronic musculoskeletal conditions are the leading cause of disability worldwide. The World Health Organization estimates that approximately 1.71 billion people have musculoskeletal conditions worldwide. They cause a significant economic burden on the NHS. £5 billion of England's yearly NHS budget goes towards the treatment of musculoskeletal conditions.

Disability from the initial pain is worsened by immobility, which will cause a loss of muscle mass and fitness and an increased risk of falls, further injury, and diseases associated with poor activity (such as heart attacks and some cancers). In chronic musculoskeletal pain conditions, providing information and participating in exercise programmes are commonly used. However, there are no evidence-based recommendations on which plans are the most effective.

The "Free from Pain" exercise programme is a fusion of three different generally accepted exercise programmes. Therapeutic exercise programmes exist for individual body parts, but there is no single generalised exercise programme that targets all body parts. Hence, the creation of this fusion of programmes. The three programmes are the Otago exercises for lower body strength and balance, the motor control exercises for the lower back and the isometric exercises for the neck and shoulder. The Otago exercise program (OEP) was developed by Robertson and Campbell for the New Zealand accident compensation corporation (ACC). The aim of the programme was to improve balance and strength in patients to prevent falls. The Otago exercise programme has also been identified as an effective intervention in community-dwelling older adults for coping with musculoskeletal pain.

Educational information leaflets will also be provided as part of the programme. These comprise an introductory leaflet, in addition to 12 reasons to exercise and 12 metaphor leaflets. The 12 reasons to exercise leaflets provide evidence-based information regarding the effects exercise can have on health. The 12 metaphor leaflets will contain metaphors used by the lead investigator in his practice over many years. These metaphors attempt to link everyday life with health, allowing laypersons to better understand the importance of certain lifestyle choices in regard to maintaining health. It will be recommended to participants that they read one reason to exercise leaflet and one metaphor each week for 12 weeks to ensure that they absorb the information fully and do not overbear themselves with information.

This is a randomised control trial feasibility study which will be conducted over an 18-month period, during which participants will be asked to provide data in the form of completed surveys three times, at baseline, 3 months, and 6 months. The aim of this randomised control trial feasibility study is to determine the effectiveness of the "Free from Pain" exercise and information programme. The complete programme provides exercises and information for people over the age of 60 in reducing early osteoarthritic and generalised musculoskeletal pain and fear of falling. The study will compare the effects of 2 versions of the Free from Pain programme to ascertain which is the most effective.

The study population will include 60 participants who will be split into 2 groups. One group will carry out the exercise classes independently at home, whereas the other group will participate in the online zoom exercise classes with a trained individual leading the class.

Eligibility criteria: Inclusion Criteria:

* 60 years of age +
* Has early osteoarthritic / generalised musculoskeletal pain

Exclusion Criteria:

* Lacking the physical ability or cardiovascular fitness required to participate in an exercise programme. This criterion will be explained on the participant information sheet by stating, "If you are unable to walk up a flight of stairs without getting breathless, please do not apply for participation in this study". This will also be confirmed in the initial consultation, during which Dr. Ampat will once again ask participants this question.
* Self-reported lack of mental ability to participate in the exercise programme.
* Have had a lower-limb joint (hip or knee) replacement, as some of the exercises may be contra-indicative to these conditions.

Primary outcomes:
measure: Changes in Musculoskeletal Health Questionnaire scores (MSK-HQ)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
measure: Changes in Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Secondary outcomes:
measure: Usefulness scale for patient information material (USE)
timeFrame: 6 months
measure: Changes in Short Falls Efficacy Scale International (Short FES-I)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
measure: 6-point Likert Scale
timeFrame: 6 months
Other outcomes:
measure: Emergence of adverse effects in the form of additional pain as assessed by a Visual Analogue Scale (VAS).
timeFrame: 6 months
measure: Recruitment and retention rates as assessed by summary statistics and 95% confidence intervals.
timeFrame: 6 months
Locations:
city: Southport
country: United Kingdom
facility: Talita Cumi LTD.
state: Merseyside
Study officials:
affiliation: National Health Service
name: George Ampat
role: PRINCIPAL_INVESTIGATOR
References:
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