Free From Pain Exercise Programme Study

Study Overview
=================
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.

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

Conditions
-----------------
Musculoskeletal Pain, Fear of Falling

Intervention / Treatment
-----------------
* Other: Free From Pain Exercise Programme Variation 1
* Other: Free From Pain Exercise Programme Variation 2


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free From Pain Exercise Programme Variation 1<br>Participants will have the initial online consultation and will be provided with the exercise booklet and the 12 information/metaphor leaflets. The ongoing 12 Zoom online sessions are not included in this option. Instead, participants will be asked to independently engage in the exercises within the exercise booklet. They will be advised to either do all 3 sets of exercises 3 times a week or to do the neck and low back exercises twice a week and the Otago exercises 3 times a week. The exercises should take around an hour to complete each day. The ideal plan would be as follows: Monday - Otago exercises. Tuesday - Neck and Back exercises. Wednesday - Otago exercises. Thursday - Rest day. Friday - Neck and Back exercises. Saturday - Otago exercises. Sunday - Rest day. | Other: Free From Pain Exercise Programme Variation 1<br>* Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets.<br>|
| Experimental: Free From Pain Exercise Programme Variation 2<br>Participants will have the initial online consultation and will be provided with the exercise booklet and12 information/metaphor leaflets. This variation also includes the online zoom sessions. The online zoom session will involve a short presentation and a group discussion for 15 minutes followed by a 45-minute exercise class which will be delivered by a suitably trained individual. The exercise class will include the exercises from the Otago Exercise programme + the Motor Control Exercises for low back pain + Isometric and strengthening exercise for the neck. Participants assigned to this intervention will also be asked to independently engage in the exercises within the exercise booklet. They will be advised to use the same weekly structure described previously. | Other: Free From Pain Exercise Programme Variation 2<br>* Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets, and the 12 Zoom online sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Musculoskeletal Health Questionnaire scores (MSK-HQ) | Participants will be asked to report changes in Musculoskeletal Health Questionnaire scores to assess changes in musculoskeletal pain. The MSK-HQ is scored on a range of 0-56, with a higher score indicating better MSK-HQ health status. | Baseline, 3 weeks, 6 weeks, 3 months and 6 months | 
| Changes in Pain as assessed by a Visual Analogue Scale (VAS) | Changes in pain in the back, hips, knees, ankles and feet will be assessed via a self-report Visual Analogue Scale (VAS) as follows: 0 to 10 where 0 is 'No Pain' and 10 is 'The worst imaginable pain', with total scoring range of 0-50. | Baseline, 3 weeks, 6 weeks, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness scale for patient information material (USE) | Reports using the usefulness scale for patient information material (USE) will be collected to assess the usefulness of the information leaflets provided. A maximum total score of 90 suggests that the participant 'completely agrees' with nine positive statements regarding the usefullness of the information material provided, whilst a minimum score of 0 suggests that they 'completely disagree' with said statements. | 6 months | 
| Changes in Short Falls Efficacy Scale International (Short FES-I) | Changes in scores on the Short Falls Efficacy Scale Internation (short FES-I) to assess improvements regarding fear of falling, where a minimum score of 7 means 'no concern about falling' and a maximum score of 28 means 'severe concern about falling'. | Baseline, 3 weeks, 6 weeks, 3 months and 6 months | 
| 6-point Likert Scale | Upon completion of the study, participants will be asked to rate on a 0-5 likert scale (where 0 means 'extremely likely' and 5 means 'extremely unlikely') how likely they are to recommend the exercise programme to friends or family who may require it. | 6 months |