Musculoskeletal PainNCT05091671
Free From Pain Exercise Programme Study
A study testing Free From Pain Exercise Programme Variation 1 and Free From Pain Exercise Programme Variation 2 in people with Musculoskeletal Pain and Fear of Falling, run by Talita Cumi Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Fear of Falling
- What is being tested?
- Free From Pain Exercise Programme Variation 1 and Free From Pain Exercise Programme Variation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age +
- Has early osteoarthritic / generalised musculoskeletal pain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Musculoskeletal Pain, Fear of Falling
- Being tested
- Free From Pain Exercise Programme Variation 1, Free From Pain Exercise Programme Variation 2
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free From Pain Exercise Programme Variation 1Other
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 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Free From Pain Exercise Programme Variation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Secondary outcomes (3)
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.
Measured: 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'.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start28 Feb 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talita Cumi Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Ampat, Principal investigator, National Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091671
- Sponsor's protocol ID
- FFPETFETS004
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication
Publications
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.
PubMed 27496243Kempen 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.
PubMed 18032400Holzel 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.
PubMed 25927192World 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.
PubMed 17537741Gillespie 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.
PubMed 22972103Hedley 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.
PubMed 20673075Nyman 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.
PubMed 21875865Stiggelbout 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.
PubMed 15980075Campbell 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.
PubMed 9366737Cederbom 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.
PubMed 31118594Shiri 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.
PubMed 29053873O'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.
PubMed 9431633Bystrom 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.
PubMed 23492976
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05091671
- Acronym / sponsor ID
- FFPETFETS004
- Conditions
- Musculoskeletal Pain, Fear of Falling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Talita Cumi Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free From Pain Exercise Programme Variation 1 | Active comparator | Other: Free From Pain Exercise Programme Variation 1Participants 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 2 | Experimental | Other: Free From Pain Exercise Programme Variation 2Participants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years of age +
- Has early osteoarthritic / generalised musculoskeletal pain
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free From Pain Exercise Programme Variation 1Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets. | Other | Free From Pain Exercise Programme Variation 1 |
| Free From Pain Exercise Programme Variation 2Includes the initial 45-minute consultation + the exercise booklet + the 12 reasons to exercise leaflets + the 12 metaphor leaflets, and the 12 Zoom online sessions. | Other | Free From Pain Exercise Programme Variation 2 |
Primary outcome
Changes in Musculoskeletal Health Questionnaire scores (MSK-HQ)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
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.
Changes in Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
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.
3 secondary outcomes
Usefulness scale for patient information material (USE)
Time frame: 6 months
Changes in Short Falls Efficacy Scale International (Short FES-I)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
6-point Likert Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Background: PubMed 27496243Hill 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.
- Background: PubMed 18032400Kempen 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.
- Background: PubMed 25927192Holzel 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.
- Results publicationWorld Health Organisation (WHO) (2021). Musculoskeletal Conditions [Fact Sheet]. [Cited January 2021]. Retrieved from: https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions
- Results publicationArthritis Research UK. Understanding Arthritis: A Parliamentary Guide to Musculoskeletal Health. Chesterfield: Arthritis Research UK; 2013.
- Results publication: PubMed 17537741Baker 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.
- Results publication: PubMed 22972103Gillespie 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.
- Results publication: PubMed 20673075Hedley 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.
- Results publication: PubMed 21875865Nyman 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.
- Results publication: PubMed 15980075Stiggelbout 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.
- Results publication: PubMed 9366737Campbell 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.
- Results publication: PubMed 31118594Cederbom 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.
- Individual participant dataSharing planned: Yes. At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Ampat principal investigator
National Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free From Pain Exercise Programme Variation 1 and Free From Pain Exercise Programme Variation 2 in people with Musculoskeletal Pain and Fear of Falling, run by Talita Cumi Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Ampat, MS, FRCS (07871590593, geampat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Musculoskeletal Health Questionnaire scores (MSK-HQ) (time frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091671, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.