NCT03462485

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

March 2, 2018

Last Update Submit

October 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minutes

Secondary Outcomes (6)

  • Short Physical Performance Battery (SPPB)

    10 minutes

  • Assessment of Physical Activity in Frail Older People (APAFOP)

    5 minutes

  • Montreal Cognitive Assessment (MoCA)

    10 minutes

  • Caregiver assessment of quality of life (DEMQOL-Proxy)

    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)

    5 minutes

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: Golf

Control

NO INTERVENTION

Control participants will continue their normal activities.

Interventions

GolfOTHER

Eight weeks of twice-daily golf training

Golf intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to give informed consent
  • Without the physical capacity to play golf, as determined by a single-leg stance test of balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bedfordshire

Luton, Bedfordshire, LU1 3JU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

GOLF protocol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health and Ageing

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 12, 2018

Study Start

September 30, 2018

Primary Completion

March 31, 2019

Study Completion

July 31, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations