- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462485
Pilot Study of the Effects of Playing Golf on People With Dementia
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Bedfordshire
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Luton, Bedfordshire, United Kingdom, LU1 3JU
- Recruiting
- University of Bedfordshire
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Contact:
- David Hewson, PhD
- Phone Number: +44 7525 616645
- Email: david.hewson@beds.ac.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to give informed consent
- Without the physical capacity to play golf, as determined by a single-leg stance test of balance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Golf intervention
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.
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Eight weeks of twice-daily golf training
|
|
No Intervention: Control
Control participants will continue their normal activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: 10 minutes
|
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.
|
10 minutes
|
|
Assessment of Physical Activity in Frail Older People (APAFOP)
Time Frame: 5 minutes
|
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.
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5 minutes
|
|
Montreal Cognitive Assessment (MoCA)
Time Frame: 10 minutes
|
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.
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10 minutes
|
|
Caregiver assessment of quality of life (DEMQOL-Proxy)
Time Frame: 5 minutes
|
An assessment of the caregiver's impression of the quality of life of the PWD they care for.
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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
|
The C-DEMQOL will be used to assess the quality of life of caregivers of PWD.
|
5 minutes
|
|
Neuropsychiatric Inventory (NPI-Q)
Time Frame: 5 minutes
|
Caregivers will complete the short form of the NPI-Q to provide an assessment of neuropsychiatric symptoms and associated caregiver distress.
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5 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IHREC820
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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