Free From Pain Exercise Programme Study

NCT05091671 | Unknown DMC

• 1 other identifier: FFPETFETS004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Fear of Falling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Usefulness scale for patient information material (USE)

  6 months

• Changes in Short Falls Efficacy Scale International (Short FES-I)

  Baseline, 3 weeks, 6 weeks, 3 months and 6 months

• 6-point Likert Scale

  6 months

Other Outcomes (2)

• Emergence of adverse effects in the form of additional pain as assessed by a Visual Analogue Scale (VAS).

  6 months

• Recruitment and retention rates as assessed by summary statistics and 95% confidence intervals.

  6 months

Study Arms (2)

Free From Pain Exercise Programme Variation 1

ACTIVE COMPARATOR

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

Free From Pain Exercise Programme Variation 2

EXPERIMENTAL

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

Interventions

Free From Pain Exercise Programme Variation 1 OTHER

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 1

Free From Pain Exercise Programme Variation 2 OTHER

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.

Free From Pain Exercise Programme Variation 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age +
• Has early osteoarthritic / generalised musculoskeletal pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Talita Cumi Ltd.: lead

Study Sites (1)

Talita Cumi LTD.

Southport, Merseyside, PR8 3NS, United Kingdom

Location

Related Publications (17)

• 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.

  PMID: 27496243 BACKGROUND

• 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.

  PMID: 18032400 BACKGROUND

• 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.

  PMID: 25927192 BACKGROUND

• 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

  RESULT

• Arthritis Research UK. Understanding Arthritis: A Parliamentary Guide to Musculoskeletal Health. Chesterfield: Arthritis Research UK; 2013.

  RESULT

• 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.

  PMID: 17537741 RESULT

• 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.

  PMID: 22972103 RESULT

• 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.

  PMID: 20673075 RESULT

• 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.

  PMID: 21875865 RESULT

• 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.

  PMID: 15980075 RESULT

• 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.

  PMID: 9366737 RESULT

• 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.

  PMID: 31118594 RESULT

• 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.

  PMID: 29053873 RESULT

• 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.

  PMID: 9431633 RESULT

• 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.

  PMID: 23492976 RESULT

• 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.

  PMID: 25629215 RESULT

• 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.

  PMID: 29396436 RESULT

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• George Ampat

  National Health Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Ampat, MS, FRCS

CONTACT

07871590593; geampat@gmail.com

Jonathan Sims, BSc

CONTACT

01704 579337; research@ampat.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: February 28, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available at the completion of the study on 31/12/2022. It will be available for other researchers indefinitely.
• Access Criteria: The non-identifiable data will be openly available as a supplementary document to the publication.

Locations

GB (1)