None listed
Conditions
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.
Interventions
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
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed