Musculoskeletal InjuryNCT06100445
Exercise Engagement in People Over 60 at Risk of Falls
An observational study of Musculoskeletal Injury and Frailty, run by East Lancashire Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise. Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls. To explore: 1. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Musculoskeletal Injury, Frailty, Physical Inactivity
- What is being tested?
- Semi structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2024to 31 Dec 2024
- Phase
- Observational
- 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 to 95 years
- All sexes
- Adult, Older adult
Study population: This is a single centre study, based at Rossendale Health Centre. The MSK Physiotherapy Service is part of an integrated model in East Lancashire Hospitals NHS Trust (ELHT) for managing musculoskeletal, rheumatology, orthopaedic and pain conditions (https://elht.nhs.uk/services/integrated-msk-pain-and-rheumatology-service). The aim is to deliver the highest quality of care and support for patients with musculoskeletal conditions. This includes patients who have been referred following falls resulting in fractures or soft tissue injuries, and painful long-term conditions such as osteoarthritis which can impact mobility. A third of the caseload in MSK physiotherapy consists of patients over the age of 60.
Who may be able to join
- Aged 60 years or over
- At risk of falls or had a fall due to a musculoskeletal cause (pain, muscle weakness, balance issue)
- Has capacity to consent, as deemed by the direct care team and researcher
- Can communicate in English OR the use of a translation service - Able to independently participate in an interview either face-to-face or via remote means OR can use a translation service
Who cannot join
- Aged under 60
- Have a medical cause of falls OR currently under investigation for a medical cause of falls (eg/ dizziness, cardiac, visual impairment reported as being the cause of the fall as opposed to weakness or pain in lower limbs/balance issues or unsteady on feet)
- Moderate to severe cognitive impairment impairing capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Lancashire Hospitals NHS Trust
Blackburn, Lancashire, BB2 3HH
About this study
Official title: Barriers and Facilitators to Exercise Engagement in People Over 60 at Risk of Falls: an Exploratory Study
It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise.
Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls.
Read more
To explore:
- Patients' preferences to exercise format and type eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual personalized rehabilitation programme handouts
- The ability to discuss falls risk with health professionals.
- If health inequalities exist with people at risk of falls and exercising.
- Sustainability of exercise, in order to reduce the risk of falls in this population.
- The need to develop MSK internal and external facing falls management pathways.
Suitability: Patients over the age of 60, who have been identified at risk of falls, having been referred to MSK Physiotherapy in Rossendale.
'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination.
Semi structured interviews on up to ten participants. It is anticipated that this sample size will give adequate data saturation. Approximately 12 months from participant recruitment to analysis of findings.
Read the detailed description
One in three people over the age of 65 and one in two over the age of 80 will fall each year. A fall is the main reason older people attend A and E. Falls can result in soft tissue injuries and broken bones, the most significant being a hip fracture, and these often require physiotherapy input. Locally, we have above average rates of hip fracture. Falling also reduces confidence and further mobility, which can also impact on developing long term health conditions.
Research has shown that exercise can help improve the strength and balance in people over 60 at risk of falls. Balance and strength exercises have been shown in previous research to reduce the risk of falls by 25% in patient's over 60. However, in other research, 78% of patients over the age of 75 have not done exercises at home in the last 5 years.
Exploring patient views on exercises and their physiotherapy experience will help us understand why patients engage or not with exercise and improve our services.
Patients who are at risk (identified through the EMIS template) of falls and have expressed an interest in being involved in research and who meet the additional eligibility criteria will be approached by the researcher. Eligible participants interested in participating will be contacted and sent the patient information sheet and consent form. They will be contacted within two weeks to see if they want to participate and assistance with the consent form either over phone or face to face.
A copy of the consent form will be scanned into the participant notes on EMIS, and paper copies stored securely in a locked filing cabinet.
All participants will have the opportunity to ask any questions regarding consent and the study prior to commencing the interviews and data collection.
The right of the participant to refuse to participate in research study without giving reasons will be respected. All participants are free to withdraw at any time without giving reasons and without prejudicing further treatment.
Face to face interviews will be recorded via an encrypted voice Dictaphone recorder. If conducting interviews via telephone call or MS teams, then voice recordings using the encrypted dictaphone will also be used. The interview will take approximately half an hour, and patients will only be interviewed once, there will be no follow up in this study.
All participant identifiable information will be kept confidential, and a participant number will be used. Recordings will be loaded onto a password protected secure trust server, accessible only to the researcher and the original recording deleted off the Dictaphone within 48 hours (about 2 days). Once transcribed, the recording on the drive will then be deleted.
Anonymised qualitative data will be transcribed by an NIHR transcriber. Then it will be analysed using thematic analysis using NVivo version 12, or the most up to date version of NVivo, a qualitative data analysis software. All data will be anonymised prior to analysis using an allocated participant ID number.
In the unlikely event that distress will be identified, the interview will be stopped, and the reason for the distress dealt with as per normal clinical practice. The participant will be given the option to stop participating (see withdrawal from participating below), or to continue with the interview at a later time. Participants can withdraw at any time up to once the interviews have been transcribed.
Data will then be used to improve patient services in physiotherapy, as well as highlight any service pathway and health inequality needs.
- Conditions
- Musculoskeletal Injury, Frailty, Physical Inactivity, Health Behavior
- Being tested
- Semi structured interviews
- Medical subject headings
- Frailty, Sedentary Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi structured interviewsBehavioural
Gaining qualitative data
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore reasons for and against engaging with exercises at home.
By identifying themes during anaylsis of study interviews
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Patients' thoughts on service materials, provision and communication
Identify preferred exercise format and understanding of information eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or their own online personalised rehabilitation programme handouts by analysing themes of the interviews
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start26 Jan 2024
- Primary completion19 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Lancashire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Michelle Thirlwall, East Lancashire Hospitals NHS Trust
- Investigators
- James Boateng, Study chair, East Lancashire Hospitals NHS TrustElizabeth Lightbody, Study chair, National Institute for Health Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100445
- Sponsor's protocol ID
- DEV072
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Facilitators to Exercise Engagement in People Over 60 at Risk of Falls: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06100445
- Acronym / sponsor ID
- DEV072
- Conditions
- Musculoskeletal Injury, Frailty, Physical Inactivity, Health Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- East Lancashire Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Oct 2023 (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.
It is a qualitative study, using semi structured interviews to explore patient's experiences of falls and their perceptions on facilitators and barriers to exercise.
Aim: To explore reasons for and against engaging with exercises at home in participants over the age of 60 at risk of falls.
To explore:
- Patients' preferences to exercise format and type eg/ leaflet, online, access, such as the Chartered Society of Physiotherapy (CSP) chair exercises leaflet or individual personalized rehabilitation programme handouts
- The ability to discuss falls risk with health professionals.
- If health inequalities exist with people at risk of falls and exercising.
- Sustainability of exercise, in order to reduce the risk of falls in this population.
- The need to develop MSK internal and external facing falls management pathways.
Suitability: Patients over the age of 60, who have been identified at risk of falls, having been referred to MSK Physiotherapy in Rossendale.
'Risk of falls' is defined as: patient self-reports they are unsteady, had one or more fall in the last 6 months, or clinician identified a slow/unsteady gait pattern on examination.
Semi structured interviews on up to ten participants. It is anticipated that this sample size will give adequate data saturation. Approximately 12 months from participant recruitment to analysis of findings.
Detailed description
One in three people over the age of 65 and one in two over the age of 80 will fall each year. A fall is the main reason older people attend A and E. Falls can result in soft tissue injuries and broken bones, the most significant being a hip fracture, and these often require physiotherapy input. Locally, we have above average rates of hip fracture. Falling also reduces confidence and further mobility, which can also impact on developing long term health conditions.
Research has shown that exercise can help improve the strength and balance in people over 60 at risk of falls. Balance and strength exercises have been shown in previous research to reduce the risk of falls by 25% in patient's over 60. However, in other research, 78% of patients over the age of 75 have not done exercises at home in the last 5 years.
Exploring patient views on exercises and their physiotherapy experience will help us understand why patients engage or not with exercise and improve our services.
Patients who are at risk (identified through the EMIS template) of falls and have expressed an interest in being involved in research and who meet the additional eligibility criteria will be approached by the researcher. Eligible participants interested in participating will be contacted and sent the patient information sheet and consent form. They will be contacted within two weeks to see if they want to participate and assistance with the consent form either over phone or face to face.
A copy of the consent form will be scanned into the participant notes on EMIS, and paper copies stored securely in a locked filing cabinet.
All participants will have the opportunity to ask any questions regarding consent and the study prior to commencing the interviews and data collection.
The right of the participant to refuse to participate in research study without giving reasons will be respected. All participants are free to withdraw at any time without giving reasons and without prejudicing further treatment.
Face to face interviews will be recorded via an encrypted voice Dictaphone recorder. If conducting interviews via telephone call or MS teams, then voice recordings using the encrypted dictaphone will also be used. The interview will take approximately half an hour, and patients will only be interviewed once, there will be no follow up in this study.
All participant identifiable information will be kept confidential, and a participant number will be used. Recordings will be loaded onto a password protected secure trust server, accessible only to the researcher and the original recording deleted off the Dictaphone within 48 hours (about 2 days). Once transcribed, the recording on the drive will then be deleted.
Anonymised qualitative data will be transcribed by an NIHR transcriber. Then it will be analysed using thematic analysis using NVivo version 12, or the most up to date version of NVivo, a qualitative data analysis software. All data will be anonymised prior to analysis using an allocated participant ID number.
In the unlikely event that distress will be identified, the interview will be stopped, and the reason for the distress dealt with as per normal clinical practice. The participant will be given the option to stop participating (see withdrawal from participating below), or to continue with the interview at a later time. Participants can withdraw at any time up to once the interviews have been transcribed.
Data will then be used to improve patient services in physiotherapy, as well as highlight any service pathway and health inequality needs.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a single centre study, based at Rossendale Health Centre. The MSK Physiotherapy Service is part of an integrated model in East Lancashire Hospitals NHS Trust (ELHT) for managing musculoskeletal, rheumatology, orthopaedic and pain conditions (https://elht.nhs.uk/services/integrated-msk-pain-and-rheumatology-service). The aim is to deliver the highest quality of care and support for patients with musculoskeletal conditions. This includes patients who have been referred following falls resulting in fractures or soft tissue injuries, and painful long-term conditions such as osteoarthritis which can impact mobility. A third of the caseload in MSK physiotherapy consists of patients over the age of 60.
Key inclusion criteria (4 listed)
- Aged 60 years or over
- At risk of falls or had a fall due to a musculoskeletal cause (pain, muscle weakness, balance issue)
- Has capacity to consent, as deemed by the direct care team and researcher
- Can communicate in English OR the use of a translation service - Able to independently participate in an interview either face-to-face or via remote means OR can use a translation service
Key exclusion criteria (3 listed)
- Aged under 60
- Have a medical cause of falls OR currently under investigation for a medical cause of falls (eg/ dizziness, cardiac, visual impairment reported as being the cause of the fall as opposed to weakness or pain in lower limbs/balance issues or unsteady on feet)
- Moderate to severe cognitive impairment impairing capacity to consent
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 |
|---|---|---|
| Semi structured interviewsGaining qualitative data | Behavioural | – |
Primary outcome
Explore reasons for and against engaging with exercises at home.
Time frame: Through study completion, an average of 1 year
By identifying themes during anaylsis of study interviews
1 secondary outcome
Patients' thoughts on service materials, provision and communication
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Older adult perceptions of exercise in the communityLink provided by the sponsor.
- National falls data and fragility priority and frameworksLink provided by the sponsor.
- NICE guidelines, updated 2024Link provided by the sponsor.
- WHO guidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
James Boateng study chair
East Lancashire Hospitals NHS Trust
Elizabeth Lightbody study chair
National Institute for Health Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Injury and Frailty, run by East Lancashire Hospitals NHS Trust 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 4 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: finished, as of the sponsor's last update on 23 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore reasons for and against engaging with exercises at home. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.