None listed
Conditions
Brief summary
The primary aim of this randomised clinical trial was to determine whether physical activity can delay progression of cerebrovascular disease (CVD) in older adults who have mild cognitive impairment or have concerns about their memory and have at least one risk factor for CVD (eg high blood pressure, heart disease, smoking). After baseline testing, participants were randomised to either the intervention (PA) or usual care. Participants were individuals with subjective memory complaints (SMC) or MCI who were also participants in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study in Melbourne. Potential participants were initially be screened over the phone. The intervention was based on the Stages of Change model and comprised three components: the tailored, home-based PA program, the behavioural intervention package, and telephone monitoring. Pedometers were used. Participants were asked to gradually progress to 150 minutes a week of moderate-intensity activity (such as walking) for 24 months. The primary outcome of interest was change in white matter hyperintensities (WMH, which indicates CVD) as measured by magnetic resonance imaging (MRI) at baseline and after 24 months. We also used a series of well-established tests and instruments to collect cognitive, physical and clinical parameters. Follow-up assessments were conducted at 6, 12 and 24 months. At baseline and 24 months, a blood sample was taken and analysed for biomarkers of CVD and a positron emission tomography (PET) scan was performed to measure amyloid deposits in the brain.
Interventions
Participants randomised to the intervention received, one week after the baseline assessment, a 60-min individual workshop. The workshop comprised two components, physical activity (PA) and behavioural intervention (BI) program. In the workshop the facilitator outlined the PA program, explained the activities, how often they were to be done, the intensity and how to record on their exercise diary. The strategies and worksheets designed to enhance adherence to the PA in the BI program were discussed. The PA program was individually tailored for each participant taking into account their PA preferences and health limitations. Physical activity was progressively increased over a period of 8 weeks until the target time spent and intensity was satisfactorily attained. Participants were advised to perform 150 min/week of moderate home-based PA and examples were given on how this could be achieved. Participants who already perform 150 min/week PA were encouraged to increase their PA to a new feasible level (the addition of approx 50 minutes/week). The supervised intervention period was 24 months. In the first 6 months, walking was recommended, however participants were able to select other activities taking into account any health problems or other limitations. Participants were encouraged to complete the PA as 3, 50-minute sessions a week or 5, 30-minute sessions a week. After the first 6 months, in order to maintain interest and motivation, the participants had their exercise adherence, fitness results and progress reviewed in a 15-minute session as part of the 6-month reassessment. Another 15-minute review took place at the time of their 12-month reassessment. They either continued with the same exercise type or switched ti other easily accessible aerobic activities. Behavioural intervention: The BI program was based on the Stages of Change Model. This model, based on social cognitive theory (SCT) proposes that individuals move through five stages when they adopt a new behaviour: pre-contemplation, contemplation, preparation, action and maintenance. We identified each individual’s stage of PA behaviour and developed a program to move them onto the next stage. This approach was based on the development of self-efficacy (the belief that one has the ability to perform a task) to promote change. An increase in self-efficacy (SE) has been found to facilitate movement from the contemplation to the action/maintenance stage of exercise adoption. The BI program aimed to develop SE by promoting practical strategies to enhance both physical skills and self-management skills. Another key component of SCT is self-regulation. SCT purports that behaviour is changed through self efficacy and self-regulation strategies and not solely self efficacy. Self-regulation has been defined as personal regulation of goal directed behaviour or performance. In this study, as we aimed to maximise the adherence to the exercise for the 24-month intervention we also included the teaching and promotion of self-regulatory skills. The BI package was included in a resource manual given out and discussed at the first workshop. It contained information as well as worksheets for the participants to complete. In each 6-month period, one worksheet was completed per month. One additional worksheet were completed in the first and last month of each period. SCT concepts were reinforced during telephone calls and via the newsletters. Six standardised and structured 15-min telephone calls were made to participants during the first 6 months. In the second and subsequent three 6-month periods, there were four telephone support calls. Newsletters, sent out at regular intervals, supplemented contact with the participants. In the first six months, five newsletters were sent. In each of the remaining 6-month periods, four newsletters were sent. Participants were given a PA calendar to complete and return to the research centre by reply paid post each month. Pedometers were given to the participants for the duration of the study and midway through each 6-month period they were asked to record their daily steps for four weeks whilst trying to reach a personalised target. These strategies combined met the recommendations for best practice for the maintenance of PA in the long-term.
Sponsors
Study design
Eligibility
Inclusion criteria
Community dwelling Diagnosis of SMC or MCI Presence of at least one CVD risk factor English Speaker Willingness and ability to provide written informed consent
Exclusion criteria
Baseline Mini-Mental State Examination (MMSE) score < 24 Diagnosis of dementia Unable to undergo MRI or PET scans Geriatric Depression Scale (GDS-15) score > 6 Unstable or life threatening disease or illness that could lead to difficulty complying with the protocol Medical condition that contraindicates physical activity Severe visual or auditory impairment History of chronic alcohol abuse within the past 5 years Unable to attend the follow-up assessments