DementiaNCT03462485
Pilot Study of the Effects of Playing Golf on People With Dementia
A study testing Golf in people with Dementia, run by University of Bedfordshire at 1 site in United Kingdom.
Trial summary
The research question for this study is whether golf is a suitable physical activity for people with dementia (PWD). It follows a qualitative pilot study in Lincoln where PWD enjoyed the activity and caregivers appreciated the service. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Golf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2018to 31 Jul 2019
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with dementia (any dementia)
- Receiving post-diagnostic support
- The capacity to give informed consent
- The physical capacity to play golf as determined by a single-leg stance test of balance
Who cannot join
- Unable to give informed consent
- Without the physical capacity to play golf, as determined by a single-leg stance test of balance
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Bedfordshire
Luton, Bedfordshire, LU1 3JU
David Hewson, PhD, +44 7525 616645, david.hewson@beds.ac.uk
About this study
Official title: Pilot Study on the Effects of Participating in a Dementia-friendly Golf Programme on People With Dementia and Their Informal Caregivers
The research question for this study is whether golf is a suitable physical activity for people with dementia (PWD). It follows a qualitative pilot study in Lincoln where PWD enjoyed the activity and caregivers appreciated the service. Golf combines many desirable elements in a physical activity programme that include being outdoors, social, cognitively challenging, no reaction-time component, and being a typical everyday activity. The length of time that golf sessions last could also offer a potential respite from care for caregivers.
Participants will be people with dementia and their caregivers. Eligibility criteria will include having been clinically diagnosed with dementia, being able to stand on one leg for at least six seconds to ensure participants are able to balance sufficiently well to be able to play golf. The study will be undertaken at The London Shire Golf Club, with the golf training provided by the Golf Trust, which is a charitable foundation experienced in providing golf training to people with a range of different disabilities.
The randomised controlled trial study will last 16 weeks, with a partial crossover design. The experimental group with have two eight-week periods of golf while the control group will have eight weeks without golf, then the golf intervention. There will be two 150-min sessions each week, starting with 30 minutes socialising, then 90 minutes playing golf, then 30 minutes socialising. The golf sessions will progress from putting, to chipping, and then a full swing, with sessions taking place on a nine-hole golf course. Participants will be evaluated before and after each eight-week period for physical function, physical activity level, cognitive function, and quality of life. Their caregivers will also provide information related to the PWD in terms of quality of life and psychopathology in dementia, as well as their own quality of life.
- Conditions
- Dementia
- Being tested
- Golf
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolfOther
Eight weeks of twice-daily golf training
| Study group | Role | What they receive |
|---|---|---|
| Golf intervention | Experimental | The golf intervention will be an eight-week golf programme in which participants will be taught to play golf in two 150-min sessions each week. Each session will begin with 30 minutes of socialising, then 90 minutes playing golf, followed by another 30 minutes socialising. The golf sessions will progress from putting, to chipping, and then a full swing, with sessions taking place on a nine-hole golf course. Receives: Other: Golf |
| Control | No intervention | Control participants will continue their normal activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life will be assessed using the DEMQOL, which is a 28-item scale that was designed for use with all stages of dementia, and is filled in by the interviewer along with with the participant.
Measured: 5 minutes
Secondary outcomes (6)
Short Physical Performance Battery (SPPB)
Physical function will be assessed using the SPPB, which consists of three tests to measure balance, walking speed, and muscular performance standing up from a chair.
Measured: 10 minutes
Assessment of Physical Activity in Frail Older People (APAFOP)
Physical activity levels will be recorded using the APAFOP, which uses more common activities in older people such as walking, standing, sitting, and lying, which are given intensity ratings and are more typical of the types of activities of older PWD.
Measured: 5 minutes
Montreal Cognitive Assessment (MoCA)
The MoCA is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Measured: 10 minutes
Caregiver assessment of quality of life (DEMQOL-Proxy)
An assessment of the caregiver's impression of the quality of life of the PWD they care for.
Measured: 5 minutes
The C-DEMQOL will be used to assess the quality of life of caregivers of PWD. Quality of life of caregivers (C-DEMQOL)
The C-DEMQOL will be used to assess the quality of life of caregivers of PWD.
Measured: 5 minutes
Neuropsychiatric Inventory (NPI-Q)
Caregivers will complete the short form of the NPI-Q to provide an assessment of neuropsychiatric symptoms and associated caregiver distress.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start30 Sep 2018 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The project will be a randomised controlled trial with a partial crossover. Each condition will be followed for eight weeks, with the crossover occurring after eight weeks for the control group. The intervention group will continue for the full sixteen weeks.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bedfordshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof David Hewson, University of Bedfordshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462485
- Sponsor's protocol ID
- IHREC820
- Status last verified
- Oct 2018
- First submitted
- 2 Mar 2018
- Last updated
- 11 Oct 2018
- 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 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Participating in a Dementia-friendly Golf Programme on People With Dementia and Their Informal Caregivers
- ClinicalTrials.gov ID
- NCT03462485
- Acronym / sponsor ID
- IHREC820
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BedfordshireUniversity, hospital or other
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 12 Mar 2018 (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.
The research question for this study is whether golf is a suitable physical activity for people with dementia (PWD). It follows a qualitative pilot study in Lincoln where PWD enjoyed the activity and caregivers appreciated the service. Golf combines many desirable elements in a physical activity programme that include being outdoors, social, cognitively challenging, no reaction-time component, and being a typical everyday activity. The length of time that golf sessions last could also offer a potential respite from care for caregivers.
Participants will be people with dementia and their caregivers. Eligibility criteria will include having been clinically diagnosed with dementia, being able to stand on one leg for at least six seconds to ensure participants are able to balance sufficiently well to be able to play golf. The study will be undertaken at The London Shire Golf Club, with the golf training provided by the Golf Trust, which is a charitable foundation experienced in providing golf training to people with a range of different disabilities.
The randomised controlled trial study will last 16 weeks, with a partial crossover design. The experimental group with have two eight-week periods of golf while the control group will have eight weeks without golf, then the golf intervention. There will be two 150-min sessions each week, starting with 30 minutes socialising, then 90 minutes playing golf, then 30 minutes socialising. The golf sessions will progress from putting, to chipping, and then a full swing, with sessions taking place on a nine-hole golf course. Participants will be evaluated before and after each eight-week period for physical function, physical activity level, cognitive function, and quality of life. Their caregivers will also provide information related to the PWD in terms of quality of life and psychopathology in dementia, as well as their own quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The project will be a randomised controlled trial with a partial crossover. Each condition will be followed for eight weeks, with the crossover occurring after eight weeks for the control group. The intervention group will continue for the full sixteen weeks.
| Arm | Type | Receives |
|---|---|---|
| Golf intervention | Experimental | Other: GolfThe golf intervention will be an eight-week golf programme in which participants will be taught to play golf in two 150-min sessions each week. Each session will begin with 30 minutes of socialising, then 90 minutes playing golf, followed by another 30 minutes socialising. The golf sessions will progress from putting, to chipping, and then a full swing, with sessions taking place on a nine-hole golf course. |
| Control | No intervention | –Control participants will continue their normal activities. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically diagnosed with dementia (any dementia)
- Receiving post-diagnostic support
- The capacity to give informed consent
- The physical capacity to play golf as determined by a single-leg stance test of balance
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Without the physical capacity to play golf, as determined by a single-leg stance test of balance
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 |
|---|---|---|
| GolfEight weeks of twice-daily golf training | Other | Golf intervention |
Primary outcome
Quality of life
Time frame: 5 minutes
Quality of life will be assessed using the DEMQOL, which is a 28-item scale that was designed for use with all stages of dementia, and is filled in by the interviewer along with with the participant.
6 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: 10 minutes
Assessment of Physical Activity in Frail Older People (APAFOP)
Time frame: 5 minutes
Montreal Cognitive Assessment (MoCA)
Time frame: 10 minutes
Caregiver assessment of quality of life (DEMQOL-Proxy)
Time frame: 5 minutes
The C-DEMQOL will be used to assess the quality of life of caregivers of PWD. Quality of life of caregivers (C-DEMQOL)
Time frame: 5 minutes
Neuropsychiatric Inventory (NPI-Q)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golf in people with Dementia, run by University of Bedfordshire 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 2 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 11 Oct 2018. 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 David Hewson, PhD (+44 7525 616645, david.hewson@beds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 5 minutes). 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 11 Oct 2018.