Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000323729
Ethics application status
Approved
Date submitted
3/02/2022
Date registered
21/02/2022
Date last updated
2/03/2023
Date data sharing statement initially provided
21/02/2022
Date results information initially provided
2/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a home-based physical activity program on metabolic syndrome in Ghanaian adults with type 2 diabetes mellitus: a feasibility randomized controlled trial
Scientific title
Effect of a home-based physical activity program on metabolic syndrome in Ghanaian adults with type 2 diabetes mellitus: a feasibility randomized controlled trial
Secondary ID [1] 306156 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes 324965 0
metabolic syndrome 324966 0
Condition category
Condition code
Metabolic and Endocrine 322400 322400 0 0
Diabetes
Metabolic and Endocrine 322594 322594 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to their usual diabetes care, participants in the intervention group will undergo a 12-week home-based physical activity program. The exercise goal for the intervention group (IG) is at least 120 minutes/week of exercise over at least three days/week. In total, the IG will engage in 36 sessions of exercise over the 12-week period, with each session lasting between 35-45 minutes. Each exercise session will be structured as follows:
1. 3 minutes of warm-up (stretching exercises);
2. 30 minutes of aerobic exercise (walking) at moderate pace (4.5-5.1km/h = 3.5 MET) or brisk pace (5.6 km/h = 4.3 MET) (Ainsworth et al., 2011).
3. 10 minutes of resistance exercise (exercises targeting upper and lower large body muscles using TheraBand). The specific resistance exercise prescribed in this program will be: chest press, shoulder curls targeting the upper body muscles, and leg press will target lower body muscles;
4. 2 minutes of cool-down (stretching exercises).

Participants in the control will maintain their usual diabetes care including hypoglycaemic medication, recommended diet, and foot care. They will be encouraged to continue their usual PA levels. They will not be contacted during the RCT and will attend all medical appointments as organized by hospital staff.

During the participants’ weekly visit to the physiotherapy centre, the physical therapist (PT) will assess exercise adherence and safety using the PT checklist for exercise adherence and safety. The PT will ask participants about which exercise they performed during the week, as well as the length and frequency of those exercises. The PT will also ask about any exercise-related complication/s they encountered when undertaking exercise. All exercise sessions completed at the physiotherapy centre will also be documented by the PT. Participants will be given an Exercise Diary to be used to document home exercises. They will record in the diary the type of exercise, frequency, duration, and any complication experienced.
Intervention code [1] 322643 0
Rehabilitation
Comparator / control treatment
Control group will continue with their usual diabetes care in Ghana which involves hypoglycemic medication, nutrition advise, exercise advise, foot care, regular follow-up visit to hospital. Currently, there is no structured physical activity program for people with type 2 diabetes in Ghana.
Control group
Active

Outcomes
Primary outcome [1] 330162 0
The primary outcome is a change in Metabolic syndrome markers (blood pressure, triglycerides, waist circumference, fasting blood glucose, and high density lipoprotein) in Ghanaian adults with T2DM who participate in a 12-week PA program, compared to those who receive usual diabetes care. Blood pressure will be assessed using sphygmomanometer. Triglycerides, fasting blood glucose, and high-density lipoprotein will be assessed by blood test. Waist circumference will be taken by measuring the mid-point between the lower costal margin and iliac crest.
Timepoint [1] 330162 0
12-weeks follow-up after starting the treatment.
Secondary outcome [1] 405089 0
a change in quality of life (QoL) in Ghanaian adults with T2DM who participate in a 12-week PA program, compared to those who receive usual diabetes care. QoL will be assessed using the Short Form Health Survey – version 2 (SF-12V2).
Timepoint [1] 405089 0
12-weeks follow-up after starting the treatment.
Secondary outcome [2] 405091 0
assess feasibility of implementation, determined by measures of safety. Safety will be assessed as a composite of the physical therapist's checklist for exercise adherence and safety and the participants’ exercise diary. Both tools were designed by the research team specifically for this study.
Timepoint [2] 405091 0
Daily assessment and 12 weeks follow-up after starting treatment.
Secondary outcome [3] 406037 0
assess feasibility of implementation, determined by measures of adherence. Adherence will be assessed as a composite of the physical therapist's checklist for exercise adherence and safety and the participants’ exercise diary. Both tools were designed by the research team specifically for this study.
Timepoint [3] 406037 0
Daily assessment and 12 weeks follow-up after starting treatment.

Eligibility
Key inclusion criteria
1. Diagnosis of T2DM and MetS, confirmed by the NDMRC nurse or physician;
2. Approval provided by the physician for the patient to participate in an exercise program;
3. Residence in Ghana for at least 2 years;
4. At least 18 years of age; and
5. Sedentary (not achieving 600 metabolic equivalent of task - minutes/week, based on international physical activity questionnaire - short form (IPAQ-SF) assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current medical conditions that preclude physical activity:
• significant cardiac/respiratory diseases (e.g., decompensated heart failure),
• severe osteoarthritis or arthritis,
• angina episodes during rest or with minimal exertion,
• uncontrolled arrythmias,
• psychotic disorder or cognitive deficits,
• liver or kidney failure,
• advanced renal disease
• unstable coronary artery disease,
• significant vision loss,
• cancer
• stroke
• neuromuscular problems (e.g., multiple sclerosis, chronic muscle fatigue, muscular dystrophy, Parkinson’s, cerebral palsy).
• arthritis
• limb amputation
• bone or joint problems (arthritis, osteoporosis, osteoarthritis, bone fracture, dislocations, scoliosis, spondylolisthesis and spondylolysis).
2. Frailty index score < 3. Frailty assessment will be assessed using the PRISMA-7 frailty index.
3. Pregnancy.
4. Inability to travel to the NDMRC for supervised training; and,
5. No access to a mobile phone.
6. Not receiving medical clearance from a doctor. A medical clearance note will be completed by participant’s physician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be performed using the latest version of SPSS. Descriptive statistics will be used to summarize feasibility outcomes, including frequencies, percentages, mean, SD, median, and interquartile range. Relevant parametric and non-parametric repeated measure analyses will be undertaken to measure between groups differences and changes in effect between and within the two groups. A p-value of <0.05 will be considered statistically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2022
Actual
30/05/2022
Date of last participant enrolment
Anticipated
21/06/2022
Actual
25/07/2022
Date of last data collection
Anticipated
30/09/2022
Actual
28/10/2022
Sample size
Target
90
Accrual to date
Final
87
Recruitment outside Australia
Country [1] 24509 0
Ghana
State/province [1] 24509 0
Accra

Funding & Sponsors
Funding source category [1] 310498 0
University
Name [1] 310498 0
Deakin University
Country [1] 310498 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 311663 0
None
Name [1] 311663 0
Address [1] 311663 0
Country [1] 311663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310127 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 310127 0
221 Burwood Highway, Burwood Victoria 3125
Ethics committee country [1] 310127 0
Australia
Date submitted for ethics approval [1] 310127 0
21/02/2022
Approval date [1] 310127 0
13/05/2022
Ethics approval number [1] 310127 0
2022-041
Ethics committee name [2] 312539 0
Korle-Bu Institutional Review Board
Ethics committee address [2] 312539 0
P. O. Box KB 77
Korle-Bu
Accra, Ghana.
Ethics committee country [2] 312539 0
Ghana
Date submitted for ethics approval [2] 312539 0
08/02/2022
Approval date [2] 312539 0
24/05/2022
Ethics approval number [2] 312539 0
KBTH-IRB/00011/2022

Summary
Brief summary
Background
There is high prevalence of metabolic syndrome (MetS) among people with type 2 diabetes mellitus (T2DM).
Aim
To test the preliminary effect of a 12-week culturally appropriate home-based physical activity (PA) program on metabolic syndrome (MetS) markers in Ghanaian adults with T2DM. A secondary objective was to evaluate the feasibility of the PA program.
Methods
The PA program was evaluated using a feasibility randomised controlled trial (RCT). Eighty-seven adults with T2DM who seek care at the National Diabetes Management and Research Centre of the Korle-Bu Teaching Hospital, Accra were randomized into either Control Group (CG) (n=43) or Intervention Group (IG) (n=44). Participants in the IG received the PA program in addition to their usual diabetes care; those in the CG received their usual diabetes care. Measurements were performed at baseline and 12-week follow-up. The primary outcome was a change in MetS markers (blood pressure, triglycerides, waist circumference, fasting blood glucose, and high-density lipoprotein) in the IG, compared to the CG. Secondary outcomes were feasibility of implementation, determined by measures of safety and participation.
Results
Following the 12-week PA program, participants in the IG showed improvement in fasting blood glucose, waist circumference, and systolic blood pressure. There was no statistical difference between the IG and CG regarding high-density lipoprotein, triglycerides, and diastolic blood pressure. Mets prevalence was reduced in the IG compared to CG (51.2% Vs. 83.3%). MetS severity score also improved in the IG compared to the CG (8.8% vs. 0.5%). The IG had improvement in two of the eight SF-12 dimensions (physical function and vitality) compared to the CG, resulting in significant improvement in the physical component summary. There was no significant difference between the IG and CG regarding the mental component summary. Thirty-two (72.7%) participants completed the 12-week program (all 36 sessions at home and facility) indicating feasibility and acceptability. Another 11 (25%) of participants completed 80% of the exercise sessions. Reasons for missing sessions included tight work demands, other social commitments, not feeling well, and long travel hours for weekly facility exercise session. No adverse events were reported during the entire project.
Conclusion
It was feasible and safe in implementing the culturally appropriate PA program. The intervention has the potential to improve MetS and quality of life (QoL) in Ghanaian adults with T2DM. The findings can be used to inform the design of a future large-scale RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116570 0
Prof Andrea Driscoll
Address 116570 0
school of Nursing and Midwifery, Deakin University, 221 Burwood Highway, Burwood Victoria 3125
Country 116570 0
Australia
Phone 116570 0
+61 3 925 17212
Fax 116570 0
Email 116570 0
andrea.driscoll@deakin.edu.au
Contact person for public queries
Name 116571 0
Mr Mohammed Amin
Address 116571 0
school of Nursing and Midwifery, Deakin University, 221 Burwood Highway, Burwood Victoria 3125
Country 116571 0
Australia
Phone 116571 0
+61 452074801
Fax 116571 0
Email 116571 0
aminmo@deakin.edu.au
Contact person for scientific queries
Name 116572 0
Mr Mohammed Amin
Address 116572 0
school of Nursing and Midwifery, Deakin University, 221 Burwood Highway, Burwood Victoria 3125
Country 116572 0
Australia
Phone 116572 0
+61 452074801
Fax 116572 0
Email 116572 0
aminmo@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected will remain confidential. Publications and reports will be reported as grouped data, protecting participants’ anonymity


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 383378-(Uploaded-01-03-2023-09-50-47)-Basic results summary.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving Metabolic Syndrome in Ghanaian Adults with Type 2 Diabetes through a Home-Based Physical Activity Program: A Feasibility Randomised Controlled Trial.2023https://dx.doi.org/10.3390/ijerph20085518
N.B. These documents automatically identified may not have been verified by the study sponsor.