Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-02-28
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Free From Pain Exercise Programme Variation 1
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.
Free From Pain Exercise Programme Variation 1
Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets.
Free From Pain Exercise Programme Variation 2
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.
Free From Pain Exercise Programme Variation 2
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.
Interventions
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Free From Pain Exercise Programme Variation 1
Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets.
Free From Pain Exercise Programme Variation 2
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.
Eligibility Criteria
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Inclusion Criteria
* Has early osteoarthritic / generalised musculoskeletal pain
Exclusion Criteria
* 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.
60 Years
ALL
Yes
Sponsors
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Talita Cumi Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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George Ampat
Role: PRINCIPAL_INVESTIGATOR
National Health Service
Locations
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Talita Cumi LTD.
Southport, Merseyside, United Kingdom
Countries
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Central Contacts
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References
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Hill JC, Kang S, Benedetto E, Myers H, Blackburn S, Smith S, Dunn KM, Hay E, Rees J, Beard D, Glyn-Jones S, Barker K, Ellis B, Fitzpatrick R, Price A. Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways. BMJ Open. 2016 Aug 5;6(8):e012331. doi: 10.1136/bmjopen-2016-012331.
Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20.
Holzel LP, Ries Z, Dirmaier J, Zill JM, Kriston L, Klesse C, Harter M, Bermejo I. Usefulness scale for patient information material (USE) - development and psychometric properties. BMC Med Inform Decis Mak. 2015 Apr 19;15:34. doi: 10.1186/s12911-015-0153-7.
World Health Organisation (WHO) (2021). Musculoskeletal Conditions [Fact Sheet]. [Cited January 2021]. Retrieved from: https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions
Arthritis Research UK. Understanding Arthritis: A Parliamentary Guide to Musculoskeletal Health. Chesterfield: Arthritis Research UK; 2013.
Baker MK, Atlantis E, Fiatarone Singh MA. Multi-modal exercise programs for older adults. Age Ageing. 2007 Jul;36(4):375-81. doi: 10.1093/ageing/afm054. Epub 2007 May 30.
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
Hedley L, Suckley N, Robinson L, Dawson P. Staying Steady: a community-based exercise initiative for falls prevention. Physiother Theory Pract. 2010 Oct;26(7):425-38. doi: 10.3109/09593980903585059.
Nyman SR, Victor CR. Older people's participation in and engagement with falls prevention interventions in community settings: an augment to the Cochrane systematic review. Age Ageing. 2012 Jan;41(1):16-23. doi: 10.1093/ageing/afr103. Epub 2011 Aug 28.
Stiggelbout M, Hopman-Rock M, Crone M, Lechner L, van Mechelen W. Predicting older adults' maintenance in exercise participation using an integrated social psychological model. Health Educ Res. 2006 Feb;21(1):1-14. doi: 10.1093/her/cyh037. Epub 2005 Jun 24.
Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.
Cederbom S, Arkkukangas M. Impact of the fall prevention Otago Exercise Programme on pain among community-dwelling older adults: a short- and long-term follow-up study. Clin Interv Aging. 2019 Apr 26;14:721-726. doi: 10.2147/CIA.S200188. eCollection 2019.
Shiri R, Coggon D, Falah-Hassani K. Exercise for the Prevention of Low Back Pain: Systematic Review and Meta-Analysis of Controlled Trials. Am J Epidemiol. 2018 May 1;187(5):1093-1101. doi: 10.1093/aje/kwx337.
O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.
Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.
Liao CD, Tsauo JY, Huang SW, Ku JW, Hsiao DJ, Liou TH. Effects of elastic band exercise on lean mass and physical capacity in older women with sarcopenic obesity: A randomized controlled trial. Sci Rep. 2018 Feb 2;8(1):2317. doi: 10.1038/s41598-018-20677-7.
Other Identifiers
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FFPETFETS004
Identifier Type: -
Identifier Source: org_study_id
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