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Trial record 4 of 224 for:    Dementia | United Kingdom

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

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ClinicalTrials.gov Identifier: NCT03462485
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Prof David Hewson, University of Bedfordshire

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.


Condition or disease Intervention/treatment Phase
Dementia Other: Golf Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Pilot Study on the Effects of Participating in a Dementia-friendly Golf Programme on People With Dementia and Their Informal Caregivers
Estimated Study Start Date : September 30, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.
Other: Golf
Eight weeks of twice-daily golf training

No Intervention: Control
Control participants will continue their normal activities.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462485


Contacts
Contact: David Hewson, PhD +44 7525 616645 david.hewson@beds.ac.uk
Contact: Charlotte Poynter, BSc +44 7983 112674 charlotte.poynter@study.beds.ac.uk

Locations
United Kingdom
University of Bedfordshire Recruiting
Luton, Bedfordshire, United Kingdom, LU1 3JU
Contact: David Hewson, PhD    +44 7525 616645    david.hewson@beds.ac.uk   
Sponsors and Collaborators
University of Bedfordshire

Responsible Party: Prof David Hewson, Professor of Health and Ageing, University of Bedfordshire
ClinicalTrials.gov Identifier: NCT03462485     History of Changes
Other Study ID Numbers: IHREC820
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders