BRAIN Training Trial: Balance, Resistance, or INterval Training Trial: A RandomisedControlled Trial of Three Exercise Modalities in Mild Cognitive Impairment

Not Applicable

• Conditions: Mild Cognitive Impairment; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12617001440314
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-11
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Mild Cognitive Impairment (MCI) defined as the presence of all four generally accepted criteria (*)
1.1. Absence of dementia: Clinical Dementia Rating scale (CDR) score below 1.
1.2. No or minimal functional impairment due to cognition: Amsterdam IADL
Questionnaire score equal or greater than 40, rated by informant or participant if no
informant available.
1.3. Subjective memory/cognitive complaint:
a) Cognitive Change Index (CCI) scale:
Participant or informant responds to 3 or more statements with a rating of 3, 4 or 5
(‘mild to severe problem’); OR
b) Subjective memory complaint questionnaire: Participant or informant responds ‘yes’
to question (1): ‘Have you noticed difficulties with your memory?’ and ‘yes’ to questions
2 OR 3: (2)‘Have you been concerned about your memory?, (3)Have you mentioned
any concerns about memory to anyone? respectively, as per recommendations for
the assessment of subjective memory complaint.
1.4. Objective cognitive impairment: Score between 19 and 25 on the Montreal
Cognitive Assessment (MoCA).

2. Age 60 or above

3. Ambulatory without the assistance of a person

4. If from non-English speaking background, must have completed some education in English.

5. Residing in the community, including retirement villages and other senior housing or activity sites (independent level of care)

6. Willing to participate in a study which involves attending supervised exercise sessions 3 days per week for 12 months

There will be 3-stage screening, which includes: Telephone screen by research assistant of participant and informant (if available) for willingness to participate, sedentary status, no exclusionary medical history, no current mayor depression (PHQ-9 score of 9 or below), no planned move, no planned vacation for more than 4 consecutive weeks during the 12 month stuy period. This will be followed by In-person screen to assess criteria for mild cognitive impairment, and later on by In-person screen by physician to perform medical screen and stress testing (to ascertain unstable or unsuitable medical conditions).

(*) Winblad B, Palmer K, Kivipelto M, et al. Mild cognitive impairment-beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med 2004;256:240-6.

Exclusion Criteria

1. Diagnosis of dementia
2. High level residential care
3. Non-ambulatory or requiring person to assist when walking
4. 1 stroke in the past 12 months or 2 or more strokes in a lifetime
5. Cardiovascular event/surgery in the past 6 months
6. Progressive neurological disease
7. Inability to read and identify objects on a computer screen and draw on a piece of paper due to vision impairment
8. Current major depressive episode (PHQ-9 score above 9)
9. Psychosis or substance abuse according to DSM-IV criteria.
10. Alcohol abuse (Responded ‘Yes’ to questions 3 and 4 of the CAGE, and reported risky drinking behaviour using NHMRC standard criteria)
11. From a non-English speaking background (NESB) without any education in English
12. Already practicing =150 min moderate intensity exercise, PRT or HIIT regularly
13. Medical contraindications to the planned exercise due to chronic or unstable or terminal diseases
14. Planned move, or planning to be away for 4 or more consecutive weeks during the study period
15. Traumatic brain injury or >2 seizures in the past 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in overall executive domain of cognitive function score (composite measure) calculated based on the scores attained in the following tess: - Neurotrax Stroop Interference Test - Neurotrax Go-No Go Test - Neurotrax Catch Game - Trails A and B Test (Trails B minus Trails A score) - Category Fluency Test - WAIS-IV Matrix Reasoning Test[At 26 weeks and 52 weeks (primary timepoint) after randomisation. Also during the 5-yearly follow-up (24, 36, 48, 60, 72 months) after randomisation as a secondary outcome measure.]