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Pilot Study of the Effects of Playing Golf on People With Dementia

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Golf
Sponsored by
University of Bedfordshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of BedfordshireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Golf intervention

Control

Arm Description

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.

Control participants will continue their normal activities.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 2, 2018
Last Updated
October 9, 2018
Sponsor
University of Bedfordshire
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1. Study Identification

Unique Protocol Identification Number
NCT03462485
Brief Title
Pilot Study of the Effects of Playing Golf on People With Dementia
Official Title
Pilot Study on the Effects of Participating in a Dementia-friendly Golf Programme on People With Dementia and Their Informal Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2018 (Anticipated)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bedfordshire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Golf intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control participants will continue their normal activities.
Intervention Type
Other
Intervention Name(s)
Golf
Intervention Description
Eight weeks of twice-daily golf training
Primary Outcome Measure Information:
Title
Quality of life
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
10 minutes
Title
Assessment of Physical Activity in Frail Older People (APAFOP)
Description
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.
Time Frame
5 minutes
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
10 minutes
Title
Caregiver assessment of quality of life (DEMQOL-Proxy)
Description
An assessment of the caregiver's impression of the quality of life of the PWD they care for.
Time Frame
5 minutes
Title
The C-DEMQOL will be used to assess the quality of life of caregivers of PWD. Quality of life of caregivers (C-DEMQOL)
Description
The C-DEMQOL will be used to assess the quality of life of caregivers of PWD.
Time Frame
5 minutes
Title
Neuropsychiatric Inventory (NPI-Q)
Description
Caregivers will complete the short form of the NPI-Q to provide an assessment of neuropsychiatric symptoms and associated caregiver distress.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Hewson, PhD
Phone
+44 7525 616645
Email
david.hewson@beds.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Poynter, BSc
Phone
+44 7983 112674
Email
charlotte.poynter@study.beds.ac.uk
Facility Information:
Facility Name
University of Bedfordshire
City
Luton
State/Province
Bedfordshire
ZIP/Postal Code
LU1 3JU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hewson, PhD
Phone
+44 7525 616645
Email
david.hewson@beds.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of the Effects of Playing Golf on People With Dementia

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