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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00497822
• Other study ID #: KW/EX05-090
• Secondary ID: HARECCTR0500054
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2007
• Last updated: July 6, 2010
• Start date: January 2006
• Est. completion date: October 2007

Study information

• Verified date: July 2010
• Source: Hospital Authority, Hong Kong
• Contact: Doris KY Miu, Dr
• Phone: (852) 3517 5326
• Email: donnamiu[@]hotmail.com
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 2007
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Dementia

Intervention

Procedure:
• Aerobic exercise training

Locations

Country	Name	City	State
China	Kwong Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function measurement using SF-12		every 3 months for 1 year
Primary	Affective function measurement by Cornell depression score		every 3 months for 1 year
Primary	Cognitive function by MMSE and ADAS-cog		every 3 months for 1 year
Secondary	6 minutes walk, functional reach, Berg balance scale		every 3 months for 1 year
Secondary	Carer stress scale		every 3 months for 1 year
Secondary	No. of fall/restricted activity days/time spend in exercise or walking		every 3 months for 1 year

External Links

•   HAREC Clinical Trial Registry