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Trial registered on ANZCTR


Registration number
ACTRN12618001599268
Ethics application status
Approved
Date submitted
6/09/2018
Date registered
26/09/2018
Date last updated
26/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Think Dental, Be Active!: A randomised control trial using psycho-education, physical activity and oral health interventions in older adults aged >50 years old, residing in Royal Freemason Benevolent Institute residential aged care facilities.
Scientific title
Healthy Gums and Muscles for a Healthy Brain: A randomised control trial to determine the effect of using psycho-education, physical activity and oral health interventions on self-reported quality of life and systemic markers of inflammation and oxidative stress in an ageing cohort.
Secondary ID [1] 295464 0
Research Grants and Contracts, The University of Sydney
Ref # G195788 / CT19071
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults 308720 0
Physical function 308723 0
Psychological wellbeing 308724 0
Periodontitis 308726 0
Condition category
Condition code
Oral and Gastrointestinal 307662 307662 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Physical Medicine / Rehabilitation 307663 307663 0 0
Other physical medicine / rehabilitation
Public Health 307664 307664 0 0
Health promotion/education
Mental Health 307665 307665 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group-Based Exercise and Psychoeducation Program + Immediate Dental Treatment

This treatment arm will comprise a facilitated group-based physical activity and psychoeducation program of as well as a dental intervention commencing week 1 of the program.

Exercise: The exercise component of the program will comprise supervised group exercise classes, independent exercise to be completed by you at home, and weekly physical activity goals. All content and a tracking record will be provided in a workbook. The group exercise classes will be facilitated by an Accredited Exercise Physiologist every week for 12 weeks – 2x classes per week from Weeks 1-4; and 1x class per week from Weeks 5-12. The classes will involve strength exercises including bodyweight exercises such as sit-to-stand exercises, squats or wall push-ups, and may also include exercises that use bands or small weights depending on your strength and level of ability. The first couple of weeks will be utilised to assist participants with getting familiar with exercise and exercising with correct technique. It is only after this introductory stage that we will aim to be exercising at moderate intensity or 5/6 out of 10 on the Modified Borg RPE Scale. All exercises can be adjusted to account for any of the participants’ current physical concerns or limitations. Each class will be approximately one hour. Starting from week 5, the participant will be asked to engage in a home-based exercise program to complement the supervised exercise class. This will involve at least one exercise session that the participant will perform independently. An Accredited Exercise Physiologist will assist the participant with how to design an exercise program that best suits the participant’s physical health status, that is safe, and can be independently completed by the participant. These exercises can mirror those that are performed during the supervised group sessions, e.g. strength exercises, circuit training. In addition to the supervised/home-based exercise sessions, participants will be given weekly physical activity goals that will comprise tasks or exercises that are designed to improve fitness and balance. The goals will be graded throughout the program, in terms of volume, intensity and variety. For example, toward the beginning of the program, participants are asked to aim for 2000 steps more than they usually would walk per day. Toward the middle of the program, participants are asked to walk a total of at least 150 minutes per week at moderate intensity, and to also complete balance exercises that they find challenging.

Psychoeducation: These 1-hour psycho-education sessions will occur once per week, from Weeks 1 to 12. The sessions will include informative presentations provided by trained research staff on a range of topics relevant to healthy ageing such as exercising safely at home, vascular risk factors and sleep. Following the presentations, there will be time for questions and group discussion. All information from the weekly psycho-education sessions will also be provided in a workbook that has been developed for this program. Furthermore, attendance at the sessions will be recorded with attendance checklists, and the workbook will be reviewed regularly throughout the program.

Dental Treatment: Following diagnosis of dental health status from the baseline assessment, oral hygiene instructions will be provided to participants. Oran hygiene instructions will include how to brush their teeth (frequency and brushing technique) and how to clean the inter-dental spaces. You will be asked to complete the Oral Hygiene Habits (OHH) questionnaire each week during the intervention period (Weeks 1-12). You will also receive individual personalised oral treatment which involves:
a. Non-surgical periodontal treatment will be administered in weeks 1, 2, 3 and 4; which will take approximately one hour each week, as necessary. This may involve scaling of hardened dental plaque on the visible tooth and in the cavity between the tooth and the gums; and,
b. A maintenance appointment will be scheduled in week 8 for approximately 1-hour, as necessary.
If during ANY appointment with the Registered Dental Hygienist, an oral condition is identified or suspected of needing external treatment, you will be provided with a referral to seek third party treatment. The dental treatment will be overseen by a Registered Dental Hygienist.
Intervention code [1] 301781 0
Treatment: Other
Intervention code [2] 301782 0
Lifestyle
Intervention code [3] 301783 0
Behaviour
Comparator / control treatment
Workbook Exercise and Psychoeducation Program + Waitlist Dental Condition

After randomization, participants in the active waitlist control group will be given a workbook matching the psycho-education, physical activity and oral health information provided to the intervention group. This workbook has been developed for the purposes of this program. However, this group will not be receiving the facilitated program as described above. Instead, they will be sent weekly information via post to match contact from the research team provided to Group A. This content will include relevant health information and encouragement to continue with the program. To mirror the exercise advice provided to the intervention group, participants will be provided with the exercise workbook with includes the group exercise plans and individual exercise templates and guidelines. Should participants require advice or discussion of their concerns, they may contact an Accredited Exercise Physiologist from the research team.

After the 12-week active control period, participants will undergo periodontal treatment in weeks 13 to 16 – approximately one hour per week – and receive dental maintenance in week 20.
Control group
Active

Outcomes
Primary outcome [1] 306651 0
Change in self-reported quality of life as assessed by the World Health Organization - Quality of Life Questionnaire
Timepoint [1] 306651 0
All Baseline, 12 weeks (primary endpoint) and 24 weeks after randomisation
Primary outcome [2] 306652 0
Change in the markers of oxidative stress in systemic blood such as Superoxide Dismutase 2 (SOD2), Glutathione (GSH), total antioxidant capacity (TAC), Haemopoxin and 8-Hydroxydeoxyguanosine (80HdG).
Timepoint [2] 306652 0
All Baseline, 12 weeks (primary endpoint) and 24 weeks after randomisation
Primary outcome [3] 307366 0
Change in the markers of inflammation such as C-Reactive Protein (CRP), Tumor Necrosis Factor alpha (TNF-alpha), Interleukin-1 (IL-1), Interleukin-6 (IL-6), via a blood serum assay.
Timepoint [3] 307366 0
All Baseline, 12 weeks (primary endpoint) and 24 weeks after randomisation.
Secondary outcome [1] 349114 0
Change in apathy symptoms as assessed by the Apathy Evaluation Scale
Timepoint [1] 349114 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [2] 349115 0
Change in depressive symptoms as per the Hamilton Rating Scale for depression and 15-item Geriatric Depression Scale
Timepoint [2] 349115 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [3] 349116 0
Change in anxious symptoms as assessed by the 7-item Generalised Anxiety Disorder scale (GAD-7)
Timepoint [3] 349116 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [4] 349117 0
Objective change in hand grip strength via use of a hand dynamometer.
Timepoint [4] 349117 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [5] 349118 0
Objective change in 6-minute walk test
Timepoint [5] 349118 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [6] 349119 0
Objective change in 6-metre timed walk test
Timepoint [6] 349119 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [7] 349120 0
Objective change in 3-metre timed up and go test
Timepoint [7] 349120 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [8] 349121 0
Objective change in 30-second sit to stand test
Timepoint [8] 349121 0
Baseline and 12 weeks after randomization
Secondary outcome [9] 349122 0
Objective change in functional reach assessment
Timepoint [9] 349122 0
Baseline and 12 weeks after randomization
Secondary outcome [10] 349123 0
Change in self-reported oral health related quality of life via the 14-item Oral Health Impact Factor Questionnaire
Timepoint [10] 349123 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [11] 349124 0
Change in oral health status (composite measure), including oral inflammation and bio-burden, as measured by periodontal pocket charting (Florida probe), GCF, plaque and saliva.
Timepoint [11] 349124 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [12] 349125 0
Change in lipid profile via a blood serum assay.
Timepoint [12] 349125 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [13] 349126 0
Change in fasting blood glucose
Timepoint [13] 349126 0
Weekly during the 24 weeks following randomization
Secondary outcome [14] 349127 0
Change in self-reported sleep quality as assessed by the Pittsburgh Sleep Quality Index and the Healthy Brain Ageing Sleep Questionnaire
Timepoint [14] 349127 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [15] 349128 0
Change in diet and nutrition quality as assessed by the Healthy Brain Ageing Diet Questionnaire
Timepoint [15] 349128 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [16] 351628 0
Change in global cognition via the Mini-Mental State Examination
Timepoint [16] 351628 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [17] 351629 0
Objective change in verbal learning and memory performance (composite measure) as determined by the California Verbal Learning Test (CVLT)
Timepoint [17] 351629 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [18] 351630 0
Objective change in visual memory via the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [18] 351630 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [19] 351631 0
Objective change in reaction time and accuracy (composite measure) via the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [19] 351631 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [20] 351632 0
Objective change in executive function via the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [20] 351632 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [21] 351633 0
Change in oral health literacy via the Oral Health Literacy – Adult Questionnaire
Timepoint [21] 351633 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [22] 351634 0
Change in oral health habits via the Oral Health Habits Questionnaire
Timepoint [22] 351634 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [23] 351635 0
Change in health knowledge via the Healthy Brain Ageing Knowledge Questionnaire
Timepoint [23] 351635 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [24] 351636 0
To explore changes in gut microbiota that may be associated with periodontitis via stool analysis
Timepoint [24] 351636 0
Baseline, 12 weeks and 24 weeks after randomization
Secondary outcome [25] 351637 0
To explore changes in oral microbiota that may be associated with periodontitis via oral plaque analysis
Timepoint [25] 351637 0
Baseline, 12 weeks and 24 weeks after randomization

Eligibility
Key inclusion criteria
• Older than 50 years at time of inclusion.
• Be residing in Royal Freemason Benevolent Institution retirement village study sites.
• Be willing to come in for baseline, 13-week follow-up and 27-week follow-up assessments,
• If randomized to the intervention arm, be willing to participate in the weekly psycho-education sessions and implement their prescribed exercises at home.
• Have at least 8 natural teeth remaining
• Have a Periodontal Screening and Recording (PSR) score of Code 1,2,3 or 4 in one or more sextants.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a history of stroke or other neurological disorder.
• Have an intellectual disability.
• Have insufficient language skills for neuropsychological assessment.
• Have a history of schizophrenia.
• Are a current recipient of cognitive training intervention (therapist or internet-based).
• Have a history of head injury with a loss of consciousness for greater than 30 minutes.
• Have a medical condition known to affect cognition (e.g. Cancer).
• Have any exercise contraindications including unstable angina, uncontrolled cardiac failure, severe aortic stenosis, uncontrolled hypertension, symptomatic hypotension, resting tachycardia or arrhythmia, uncontrolled diabetes or acute illness/fever.
• Have severe Alzheimer’s Disease or another type of dementia or suspected dementia (score <24 on the Mini-Mental State Examination).
• Are taking Benzodiazepines (e.g. Valium/Diazepam, Normison/Temazepam).
• Have started taking any medications that may affect immune response or cognition, such as cholinesterase inhibitors (e.g. Aricept/Donepezil), either shortly before (2 months previous) or during the commencement of the trial.
• Participants with extensive and/or urgent dental therapy needs hindering full periodontal treatment, as determined through oral assessment by a Registered Dental Hygienist in conjunction with a Registered Dentist
• Have taken antibiotics within the last 3 months or undertaken periodontal therapy within the last 6 months.
• Require antibiotic prophylaxis cover for oral treatment or assessments (as determined by registered oral hygienist at screening).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features

There will be two groups of participants. During the first 12 weeks of the study procedure, one group will receive a facilitated and group-based exercise and psychoeducation program, and immediate dental treatment. Concurrently, the other group will be provided with a non-facilitated exercise and psychoeducation program in a workbook format, and will be waitlisted for the dental treatment. After the facilitated group finishes the 12-week facilitated program, the waitlist group will receive the same dental treatment as that of the facilitated group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group differences at baseline will be assessed using independent samples t-tests for continuous data and chi-squared tests for categorical data (such as gender). A repeated measures analysis of variance will be used to examine group differences in primary and secondary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
Date of last participant enrolment
Anticipated
17/05/2021
Actual
Date of last data collection
Anticipated
22/11/2021
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23237 0
2263 - Lake Haven
Recruitment postcode(s) [2] 23238 0
2325 - Cessnock
Recruitment postcode(s) [3] 23240 0
2285 - Edgeworth
Recruitment postcode(s) [4] 23241 0
2327 - Kurri Kurri

Funding & Sponsors
Funding source category [1] 300056 0
Charities/Societies/Foundations
Name [1] 300056 0
Royal Freemasons’ Benevolent Institution
Country [1] 300056 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Research Grants and Contracts
Level 6 Jane Foss Russell Building (G02)
The University of Sydney
NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 300124 0
None
Name [1] 300124 0
Address [1] 300124 0
Country [1] 300124 0
Other collaborator category [1] 280221 0
Individual
Name [1] 280221 0
Dr Shantel Duffy
Address [1] 280221 0
Faculty of Health Sciences
Level 2, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country [1] 280221 0
Australia
Other collaborator category [2] 280222 0
Individual
Name [2] 280222 0
Prof Sharon Naismith
Address [2] 280222 0
Faculty of Science
Level 2, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country [2] 280222 0
Australia
Other collaborator category [3] 280223 0
Individual
Name [3] 280223 0
A.Prof Janet Wallace
Address [3] 280223 0
Oral Health Precinct,
Faculty of Health and Medicine Loop Road
University of Newcastle
Ourimbah NSW 2258
Country [3] 280223 0
Australia
Other collaborator category [4] 280224 0
Individual
Name [4] 280224 0
Dr Loren Mowszowski
Address [4] 280224 0
Faculty of Science
Level 2, Building M02G
Brain and Mind Centre
100 Mallet Street
Camperdown NSW 2050
Country [4] 280224 0
Australia
Other collaborator category [5] 280225 0
Individual
Name [5] 280225 0
Ms Bonnie Tran
Address [5] 280225 0
Faculty of Medicine & Health
Level 2, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country [5] 280225 0
Australia
Other collaborator category [6] 280226 0
Individual
Name [6] 280226 0
Mr Bradley Skinner
Address [6] 280226 0
Faculty of Science
Level 2, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country [6] 280226 0
Australia
Other collaborator category [7] 280227 0
Individual
Name [7] 280227 0
Ms Rebecca Raeside
Address [7] 280227 0
Faculty of Dentistry
Level 3, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country [7] 280227 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300902 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 300902 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 300902 0
Australia
Date submitted for ethics approval [1] 300902 0
16/04/2018
Approval date [1] 300902 0
06/09/2018
Ethics approval number [1] 300902 0
2018/380

Summary
Brief summary
This study aims to investigate whether a 12-week combined psycho-education, exercise and oral health intervention can improve general wellbeing, cognition, mental and metabolic health in individuals residing in residential aged care. The active intervention will comprise a group-based exercise and psycho-education program with immediate dental treatment. Results will be compared to an active workbook control condition, who will be offered the oral health intervention following the 12-week intervention period.
We hypothesise that the combined psycho-education, exercise and oral health intervention can improve general wellbeing, cognition, mental health and metabolic health, and we may see a greater positive effect of the combined exercise and psychoeducation program in the facilitated group as compared to the active workbook control group. Furthermore, we may find that the dental treatment is more effective following the completion of the exercise and psychoeducation program rather than concurrently with the exercise and psychoeducation program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85218 0
Prof Joerg Eberhard
Address 85218 0
Faculty of Dentistry
Level 3, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country 85218 0
Australia
Phone 85218 0
+61437487452
Fax 85218 0
Email 85218 0
[email protected]
Contact person for public queries
Name 85219 0
Joerg Eberhard
Address 85219 0
Faculty of Dentistry
Level 3, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country 85219 0
Australia
Phone 85219 0
+61437487452
Fax 85219 0
Email 85219 0
[email protected]
Contact person for scientific queries
Name 85220 0
Joerg Eberhard
Address 85220 0
Faculty of Dentistry
Level 3, Building D17,
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country 85220 0
Australia
Phone 85220 0
+61437487452
Fax 85220 0
Email 85220 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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