Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001152819
Ethics application status
Approved
Date submitted
7/06/2021
Date registered
26/08/2021
Date last updated
9/08/2022
Date data sharing statement initially provided
26/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The EXCEL Study (EXercise for Cognitive hEaLth) for middle and older aged adults with memory complaints and stress, depressive and/or anxiety symptoms
Scientific title
The EXCEL Study (EXercise for Cognitive hEaLth): A pilot feasibility and acceptability study of a home-based physical activity program for middle and older aged adults with memory complaints and stress, depressive and/or anxiety symptoms
Secondary ID [1] 304399 0
None
Universal Trial Number (UTN)
Trial acronym
EXCEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective memory complaints 322191 0
Mild Cognitive Impairment (MCI) 322809 0
Mild-moderate symptoms of depression 322810 0
Mild-moderate symptoms of anxiety 322811 0
Mild-moderate symptoms of stress 323270 0
Condition category
Condition code
Mental Health 319881 319881 0 0
Depression
Mental Health 319882 319882 0 0
Anxiety
Mental Health 319906 319906 0 0
Other mental health disorders
Neurological 320398 320398 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will investigate the feasibility and acceptability of a pragmatic intervention of person-centred, home-based physical activity (PA) programs to assist middle-to-older-aged people with mild cognitive and mental health concerns to adopt age-appropriate Australian PA guidelines. Specifically, participants will be concerned about their cognitive health but will not have dementia and report mild-to-moderate depressive and/or anxiety symptoms.

The intervention will include a 12-week, home based, personalised PA program delivered via information and communication technology (Zoom video or phone calls, emails and PDF resources, and online REDCap surveys). Based on participants' health, abilities and skills at baseline, they will be assigned into a PA program that best suits them. They will be placed in one of two streams (either 45-59 years or 60-80 years), and assigned an ability level of either starter or intermediate for aerobic and strength programs, and those aged 60-80 years will also be given a starter balance program with further options. All programs will be tailored by a researcher with expertise in exercise science to participants' skill and ability level, however will generally work towards participants undertaking 150 mins of moderate aerobic PA (~30 mins sessions), strength activities on 2 or more days per week, and balance activities as often as they can (for older adults only). Aerobic programs will be walking or cycling programs with a scheduled progression of increasing minutes and intensity. Strength programs will include circuits of resistance exercises, e.g. bicep curls, with increasing difficulty, repetitions and load over the 12 weeks. Balance programs will include a variety of exercises, e.g. sit to stand, to incorporate as often as possible. Participants will also be provided with an Activity Tracker, dumbbells, and/or resistance bands (appropriate to their level and wants) to motivate and assist them in completing their PA programs.

Prior to starting their PA program, participants will receive a 60-minute Zoom call with a trained Research Assistant to explain their program. They will then be provided with a PA package including a general PA guide with information about the PA guidelines, safety and tips, their individual aerobic, strength and/or balance programs, warm-up and cool-down guides, a PA diary and extra resources including videos of the exercises. The PA programs, guides, videos, and diaries were designed specifically for this study. The PA guidelines are readily available online.

The same Research Assistant will follow the participant throughout the 12 weeks in fortnightly catch-up sessions (5-20 mins each) over Zoom. The sessions will be flexible and based on the participant's needs, and include questions about how the participant is finding the program, whether there are any barriers that they need to work through, and general safety questions. These questions are intended to support and encourage the participant with education and behaviour change strategies to progress successfully. The participant's PA diary will also be reviewed in these sessions to monitor adherence.
Intervention code [1] 320757 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327760 0
This is a composite outcome:
Proportion of participants completing 150 minutes of moderate intensity aerobic physical exercise per week assessed by community health activities model program for seniors (champs) questionnaire and modified stages of change for pa behaviour scale (soc) and diaries.
Timepoint [1] 327760 0
12 weeks post-intervention commencement
Primary outcome [2] 327761 0
Proportion of participants completing greater than or equal to 150mins/week of moderate aerobic physical activity, greater than or equal to 2 strength training sessions per week, and greater than or equal to 2 balance sessions per week (only required for older adults), as determined by participant physical activity diaries, community health activities model program for seniors (champs) questionnaire and modified stages of change for pa behaviour scale (soc)
Timepoint [2] 327761 0
12 weeks post-intervention commencement
Primary outcome [3] 327762 0
The proportion of participants adhering to 66% of the PA guidelines.
There is no consensus on defining PA adherence. From similar studies in the literature, the latter is often defined as meeting 66% or more of the prescribed PA (King et al. 1997). Thus, for this study the operationalised definition of adherence will be achieving 66% of the aerobic (150 mins/wk mod PA ), strength (2/wk) and balance (as often as possible for older adults) activity recommendations.
This translates to:
• Aerobic component > 100 mins/week moderate intensity PA as determined by participant physical activity diaries, community health activities model program for seniors (CHAMPS) questionnaire and modified stages of change for pa behaviour scale (SOC).
• Strength component > 1 strength session/week as determined by participant physical activity diaries, community health activities model program for seniors (CHAMPS) questionnaire and modified stages of change for pa behaviour scale (SOC).
• Balance component > 1 balance session/week (only required for older adults) as determined by participant physical activity diaries, community health activities model program for seniors (CHAMPS) questionnaire and modified stages of change for pa behaviour scale (SOC).
Timepoint [3] 327762 0
12 weeks post-intervention commencement
Secondary outcome [1] 396498 0
Retention as a measure of feasibility and acceptability as determined by completion of the assessments at 12 weeks.
Timepoint [1] 396498 0
12 weeks post-intervention commencement
Secondary outcome [2] 396499 0
General dementia risk measured by CogDrisk (dementia risk assessment and cognitive health questionnaire) (Anstey et al., 2020)
Timepoint [2] 396499 0
12 weeks post-intervention commencement
Secondary outcome [3] 396500 0
Change in overall minutes of mod-vigorous intensity PA (includes relevant everyday activities) using the CHAMPS.
Timepoint [3] 396500 0
12 weeks post-intervention commencement
Secondary outcome [4] 396501 0
Adherence to prescribed Aerobic PA domain – Calculation of the percentage of PA completed over 12 weeks using the 12-week PA diary and the SOC.
Timepoint [4] 396501 0
12 weeks post-intervention commencement
Secondary outcome [5] 396502 0
Change in exercise specific measures of anticipated cognitive mediators of exercise behaviour change: task and barrier self-efficacy using the Modified Self-efficacy for Exercise Scale (SEES) (Resnick & Jenkins, 2000).
Timepoint [5] 396502 0
12 weeks post-intervention commencement
Secondary outcome [6] 396503 0
Change in measures of anticipated cognitive mediators of general dementia risk reduction (DRR) behaviour change: knowledge using the Dementia Knowledge Assessment Scale (DKAS) (Annear et al., 2015)
Timepoint [6] 396503 0
12 weeks post-intervention commencement
Secondary outcome [7] 396504 0
Mental health outcomes using the DASS-21 (Lovibond & Lovibond, 1995)
Timepoint [7] 396504 0
4, 8, and 12 weeks post-intervention commencement
Secondary outcome [8] 396505 0
Self-reported experience and impact of COVID-19 pandemic, using the COVID Self-Report Scale (modified to the Australian context)
Timepoint [8] 396505 0
12 weeks post-intervention commencement
Secondary outcome [9] 396506 0
Feasibility and acceptability with a focus on behaviour change using the evaluation questionnaire. The evaluation questionnaire was designed specifically for this study.
Timepoint [9] 396506 0
12 weeks post-intervention commencement
Secondary outcome [10] 398595 0
Change in overall minutes of all PA using the CHAMPS.
Timepoint [10] 398595 0
12 weeks post-intervention commencement
Secondary outcome [11] 398596 0
Adherence to prescribed Strength PA domain – Calculation of the percentage of PA completed over 12 weeks using the 12-week PA diary and the SOC
Timepoint [11] 398596 0
12 weeks post-intervention commencement
Secondary outcome [12] 398597 0
Adherence to prescribed Balance PA domain – Calculation of the percentage of PA completed over 12 weeks using the 12-week PA diary and the SOC
Timepoint [12] 398597 0
12 weeks post-intervention commencement
Secondary outcome [13] 398599 0
Change in exercise specific measures of anticipated cognitive mediators of exercise behaviour change: outcome expectations using the Modified Outcome Expectations for Exercise Scale (OEES-2) (Resnick 2005)
Timepoint [13] 398599 0
12 weeks post-intervention commencement
Secondary outcome [14] 398600 0
Change in exercise specific measures of anticipated cognitive mediators of exercise behaviour change: planning and change readiness using the Modified Exercise Benefits and Barriers Scale (EBBS) (Sechrist, Walker & Pender, 1987), action planning scale (Sniehotta et al., 2005) and SOC
Timepoint [14] 398600 0
12 weeks post-intervention commencement
Secondary outcome [15] 398602 0
Change in measures of anticipated cognitive mediators of general dementia risk reduction (DRR) behaviour change: motivation using the MCLHB-DRR (Kim et al., 2014)
Timepoint [15] 398602 0
12 weeks post-intervention commencement
Secondary outcome [16] 398603 0
Change in measures of anticipated cognitive mediators of general dementia risk reduction (DRR) behaviour change: self-efficacy using the general self-efficacy and Modified Self-efficacy for Exercise Scale (SEES) (Resnick & Jenkins, 2000).
Timepoint [16] 398603 0
12 weeks post-intervention commencement
Secondary outcome [17] 398604 0
Change in measures of anticipated cognitive mediators of general dementia risk reduction (DRR) behaviour change: planning using the action planning scale (Sniehotta et al., 2005).
Timepoint [17] 398604 0
12 weeks post-intervention commencement
Secondary outcome [18] 399798 0
Cognitive and Mental health outcomes using the CogDrisk
Timepoint [18] 399798 0
12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
• Aged between 45 and 80 years
• Living in the community
• Report concerns about cognition (by responding ‘Yes’ to the question ‘Do you think your memory or thinking (also called cognitive health) has changed' and 'Do you think your memory or thinking (also called cognitive health) is worse than other people your age?'), with or without scoring greater than or equal to 28 and less than or equal to 31 on TICS-M [indicative of Mild Cognitive Impairment (MCI)]).
• Non demented, as indicated by a score of 28 or above on the TICS-M (Bentvelzen et al., 2019; Knopman et al. 2010)
• Demonstrating mild to moderate stress, depressive and/or anxiety symptoms on the depression anxiety and stress scale (DASS-21)
• Capacity to provide informed consent
• Access to a phone and/or internet
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent
• Unable to read or write
• Inadequate English skills to participate
• Diagnosed dementia or TICS-M score less than or equal to 27 (indicative of dementia)
• Scores in the severe range on the DASS-21 greater than 20 (Depression), greater than 14(Anxiety), greater than 25(Stress) (indicative of severe depressive and/or anxiety symptoms)
• Significant acute mental illness (including schizophrenia, bipolar disorder, severe depression, eating disorder) or a past history of these disorders
• Current suicidality and/or history of suicide attempts within the last 2 years
• Alcohol use of greater than 28 standard drinks per week
• Any significant medical condition preventing participation in a moderate intensity PA program as disclosed by participants in the APSS, PAR-Q and general health screening questions
• Significant uncorrected sensory impairment preventing participation
• Living in residential aged care
• Severe mobility impairment, measured as inability to walk unaided (walking stick for safety acceptable) or a FRAT score of greater than 11 (medium-high risk) (Stapleton et al., 2009)
• BMI indicating they are underweight (less than 18.5) or very obese (greater than or equal to 38). Where appropriate, ethnicity-adjusted BMI indicators will be used (e.g. WHO expert consultation, 2004).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/06/2021
Date of last participant enrolment
Anticipated
5/11/2021
Actual
4/04/2022
Date of last data collection
Anticipated
28/02/2022
Actual
8/07/2022
Sample size
Target
70
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308768 0
Other Collaborative groups
Name [1] 308768 0
Melbourne Academic Centre for Health
Country [1] 308768 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 309673 0
None
Name [1] 309673 0
Address [1] 309673 0
Country [1] 309673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308683 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 308683 0
Ethics committee country [1] 308683 0
Australia
Date submitted for ethics approval [1] 308683 0
11/03/2021
Approval date [1] 308683 0
17/04/2021
Ethics approval number [1] 308683 0
2021-20479-16470-3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111542 0
Prof Nicola Lautenschlager
Address 111542 0
Academic Unit for Psychiatry of Old Age (AUPOA)
The University of Melbourne
151 Barry Street
Carlton, VIC 3053
Country 111542 0
Australia
Phone 111542 0
+61 3 8387 2326
Fax 111542 0
Email 111542 0
[email protected]
Contact person for public queries
Name 111543 0
Rebecca Moorhead
Address 111543 0
Academic Unit for Psychiatry of Old Age (AUPOA)
The University of Melbourne
151 Barry Street
Carlton, VIC 3053
Country 111543 0
Australia
Phone 111543 0
+61 3 8344 1879
Fax 111543 0
Email 111543 0
[email protected]
Contact person for scientific queries
Name 111544 0
Nicola Lautenschlager
Address 111544 0
Academic Unit for Psychiatry of Old Age (AUPOA)
The University of Melbourne
151 Barry Street
Carlton, VIC 3053
Country 111544 0
Australia
Phone 111544 0
+61 3 8387 2326
Fax 111544 0
Email 111544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.