A randomised clinical trial of physical activity for the treatment of older adults with mild cognitive impairment

A randomised clinical trial to evaluate the effect of physical activity on cognition and quality of life in the conditons subjective memory complaints, mild cognitive impairment and Alzheimer's disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000136606

Enrollment

170

Registered

2005-08-12

Start date

2015-06-30

Completion date

2017-04-21

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Aims: To conduct a first-ever long-term (10-15 years) follow-up of individuals at risk of Alzheimer’s disease (AD) who participated in a 6-month physical activity intervention versus usual-care to asses the effects on cognition, mental and physical health, and quality of life. Hypothesis: We hypothesise that the group who undertook the physical activity intervention will have better mental and physical outcomes and a lower rates of Alzheimer’s disease and lower use of health services. Methods: Individuals recruited into the original trial were re-contacted and invited to take part in this follow-up. In Stage 1 of the Follow-up study invitations were posted with 69 re-interviewed and data collected. In Stage 2 we propose to access information from the WA Department of Health data linkage service for those not withdrawing from the original study and those opting out of the follow-up interview to obtain information from several linked health agency databases.

Interventions

The Fitness for the Ageing Brain Study (FABS) RCT was conducted between 2004-2006 in older adults with subjective cognitive decline (SCD), with or without mild cognitive impairment (MCI) with assessments at 0, 6, 12 and 18 months. The intervention group had a 6-month home-based physical activity (PA) intervention. In Stage 1 of the long-term follow-up we will evaluate the long-term effects of that PA program on PA, cognition, function and health for this cohort after 10-15 years with a repeat of the assessments from the original trial. There is no active intervention in this period. In Stage 2 we proposed to access information from the WA Health Department data linkage service for those not withdrawing from the original study and those opting out of the follow-up interview. Both the Intervention and control group will be invited to participate in the follow-up Study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Diagnosis of Mild Cognitive Impairment, subjective Memoery Complaints or mild to moderate Alzheimer's disease.

Exclusion criteria

Clinical history of stroke, unstable or life threatening illness.

Outcome results