A Randomized Controlled Trial on the Effect of Exercise on Physical, Cognitive and Affective Function in Dementia Subjects

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00497822
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

Studies have shown conflicting results of the effect of exercise on dementia patients.

The aim of this study is to examine the role of physical activity on the risk of cognitive impairment and dementia in older persons.

To promote the benefits of aerobic exercise on dementia patients and encourage exercise prescription in the management of dementia subjects.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Procedure: Aerobic exercise training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Official Title: To Study the Effect of Exercise Training in Term of Aerobic Exercise for 3 Months, on the Physical, Cognitive and Affective Function in Dementia Subjects
• Study Start Date: Jan 1, 2006
• Anticipated Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. Physical function measurement using SF-12 [every 3 months for 1 year]

2. Affective function measurement by Cornell depression score [every 3 months for 1 year]

3. Cognitive function by MMSE and ADAS-cog [every 3 months for 1 year]

Secondary Outcome Measures

1. 6 minutes walk, functional reach, Berg balance scale [every 3 months for 1 year]

2. Carer stress scale [every 3 months for 1 year]

3. No. of fall/restricted activity days/time spend in exercise or walking [every 3 months for 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• MMSE<26

• Age >60

• Community dwelling and ambulatory

• Have a caregiver that is willing to participate and escort patient to hospital for training and assessment

Exclusion Criteria:

• MMSE<10

• live in old age home

• poor mobility, unable to attend exercise training

• no carer to bring patient to attend hospital training

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kwong Wah Hospital	Hong Kong		China

Sponsors and Collaborators

• Hospital Authority, Hong Kong

Investigators

• Principal Investigator: Doris KY Miu, Dr, Department of Medicine and Geriatrics, Kwong Wah Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00497822
• Other Study ID Numbers: KW/EX05-090; HARECCTR0500054
• First Posted: Jul 9, 2007
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Dementia
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Jul 7, 2010