Skip to content

Fitness for the Ageing Brain Study II

A multicentre randomised clinical trial to evaluate the effect of physical activity on cognitive function in patients with Alzheimer’s disease (Fitness for the Ageing Brain Study II – FABS II)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000755235
Acronym
FABS II
Enrollment
230
Registered
2009-09-01
Start date
2009-08-31
Completion date
2012-11-29
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The primary aim of this 3-site multicentre randomised controlled trial was to establish whether physical activity (PA) can decrease the rate of cognitive decline amongst patients with mild to moderate Alzheimer’s disease (AD). The main hypothesis was that participants with mild to moderate AD who were randomised to a program of PA will experience significantly less cognitive decline by the end of the intervention than participants with mild to moderate AD randomised to usual care. Previously, some of the researchers involved in this study successfully developed a PA program for participants with mild cognitive impairment (FABS) and tested this program in a pilot study with patients with mild to moderate AD.

Interventions

This 6-month study comprised a 24-week individualised home-based physical activity intervention (= 150 minutes per week moderate intensity physical activity with a focus on walking). The participants were asked to complete the sessions as 3 x 50 minutes per week. They were offered a shorter session time of 30 minutes ( ie 5 x 30 minutes/week) if they indicated that they would have difficulty complying with longer session durations. Participants received a 1 hour workshop session one on one with

This 6-month study comprised a 24-week individualised home-based physical activity intervention (= 150 minutes per week moderate intensity physical activity with a focus on walking). The participants were asked to complete the sessions as 3 x 50 minutes per week. They were offered a shorter session time of 30 minutes ( ie 5 x 30 minutes/week) if they indicated that they would have difficulty complying with longer session durations. Participants received a 1 hour workshop session one on one with an exercise physiologist at baseline. They received their own take-home resource manual containing their individualised exercise program information about exercise and safety and a behavioural education package. The material in the manual was explained to the participants during the workshop. The exercise program was carried out at home. They had the option of completing this with a carer or another person. The participants received scheduled 15-minute follow-up telephone calls (weeks 2, 4, 8, 14, 20) from the exercise physiologist. The program and scheduled worksheets in the intervention program were discussed. Five newsletters containing exercise information and material to enhance exercise compliance were also sent out to participants at regular intervals (weeks 3, 7, 11, 15) during the intervention phase. After 12 weeks the participants were sent a pedometer to wear during the exercise sessions to provide feedback and motivation for a 4 week period.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of mild to moderate AD (Mini-Mental State Examination (MMSE) score greater and equal 10/30) Contact with carer more than 10 hours per week who is willing to participate in trial Community-dwelling No unstable or lifethreatening medical condition Geriatric Depression Scale (GDS) score 7 or less (= no significant depression) Needs to understand spoken and written English Needs to be able to attend visits to the National Ageing Research Institute (NARI) No severe visual or hearing impairment No presence of significant aphasia No history of chronic alcohol abuse within the past 5 years No medical condition that contraindicates physcial activity

Exclusion criteria

Unstable or lifethreatening medical condition GDS score greater/ equal than 7 (= significant depression) Cannot understand spoken and written English Cannot attend visits to NARI Severe visual or hearing impairment Presence of significant aphasia History of chronic alcohol abuse within the past 5 years Medical condition that contraindicates physcial activity

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 30, 2026