None listed
Conditions
Brief summary
Individuals with depression and metabolic syndrome are 6.6 times more likely to develop type 2 diabetes within 5 years compared to individuals without either condition. Thus, early, robust and targeted interventions are warranted to alleviate symptoms of depression and improve the metabolic health of these at-risk individuals. The primary aims of this project are to determine the effects of progressive resistance training on insulin resistance (measured using the Homeostatic Model of Assessment-2) and depressive symptoms [assessor-rated Hamilton Depression Rating Scale (HDRS), Patient Health Questionnaire (PHQ-9) and Center for Epidemiologic Studies Depression Scale (CES-D) in adults with co-existing metabolic syndrome and major depressive disorder. Participants will be randomized to receive either progressive resistance training (PRT), 3 days per week for 12 weeks in addition to usual care from their GP, or referred to their GP for usual care. Participants randomised to the control intervention will be referred to their GP for management of their depression and metabolic syndrome. Blinded assessments will occur pre, and post intervention. This will be the first trial of PRT for individuals with co-existing major depressive disorder, metabolic syndrome and impaired glucose tolerance, and only the 5th trial of PRT in clinical depression. Primary Hypotheses 1. 12 weeks of PRT will significantly reduce insulin resistance, measured via Homeostatic Model of Assessment-2 (HOMA2-IR) compared to controls referred for General Practitioner (GP) care. 2. 12 weeks of PRT will significantly improve therapist-rated depressive symptoms [Hamilton Depression Rating Scale (HDRS)] as well as self-rated symptoms [Patient Health Questionnaire (PHQ-9)] and Center for Epidemiologic Studies Depression Scale (CES-D) compared to controls referred for GP care. Secondary Hypotheses 1. 12 weeks of PRT will significantly reduce glucose and insulin area under the curve during an oral glucose tolerance test (OGTT) compared to controls referred for GP care. 2. 12 weeks of PRT will significantly reduce glycated haemoglobin (HbA1c) compared to controls referred for GP care. 3. 12 weeks of PRT will significantly increase lean body mass (LBM) and decrease central adiposity compared to controls referred for GP care. 4. 12 weeks of PRT sill significantly improve central haemodynamics compared to controls referred for GP care. 4. Reductions in depressive symptoms will be associated with reductions in HOMA2-IR. 5. Improvements in body composition (increases in lean tissue and reductions in central adiposity), and reductions in systemic inflammation and serum cortisol will be independently associated with improvements in metabolic profile and depressive symptoms.
Interventions
Progressive Resistance Training (PRT).
The PRT intervention will include 8 machine-based/free-weight exercises involving the upper and lower body and the trunk. The intervention will be prescribed with a warm-up set followed by 3 sets of 8 repetitions at 80% of their current capacity.
Participants will train 3 days per week, for 12 weeks. Each session will last approximately 45-60 minutes. Participants will exercise in a University based gymnasium, Participants will be fully supervised throug
Progressive Resistance Training (PRT). The PRT intervention will include 8 machine-based/free-weight exercises involving the upper and lower body and the trunk. The intervention will be prescribed with a warm-up set followed by 3 sets of 8 repetitions at 80% of their current capacity. Participants will train 3 days per week, for 12 weeks. Each session will last approximately 45-60 minutes. Participants will exercise in a University based gymnasium, Participants will be fully supervised throughout the whole intervention period. Exercises will include leg press, knee extension, knee flexion, chest press, seated row, triceps, hip abduction, and plantar flexion initially. Total session time will be approximately 45 min, with a ratio of no more than 1 trainer for 4 participants. Participants will be progressed continuously throughout the intervention, guided by one repetition maximum (1RM) strength testing every 2 weeks to maintain intensity at least 80% of current maximum capacity. Participants in this group will also remain under the usual care of their GP for the management of their depression and metabolic syndrome
Sponsors
Dr Yorgi Mavros
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Major Depressive Disorder according to DSM 5 criteria, *If not receiving any treatment; PHQ-9 of 10 or higher (moderate depression) *If receiving treatment, PHQ-9 of 5 or higher (mild depression) 2. Metabolic syndrome according to IDF criteria *Central obesity (Waist circumference Men; greater than or equal to 94 cm men. Women; greater than or equal to 80 cm) and any 2 of the following: *Raised triglycerides (150 mg/dL (1.7 mmol/L) or higher, or specific treatment for this lipid abnormality) *Low HDL cholesterol (Less than 40 mg/dL (1.03 mmol/L) in men and less than 50 mg/dL (1.29 mmol/L) in women or specific treatment for this lipid abnormality *Hypertension (systolic BP of 130 or higher, or diastolic BP of 85 mm Hg or higher, or treatment of previously diagnosed hypertension) *High fasting plasma glucose ((FPG) of 100 mg/dL (5.6 mmol/L) or higher. 3. at least 40 years of age 4. Not on oral hypoglycaemics or insulin therapy 5. No diagnosis of type 2 diabetes, or not found to have type 2 diabetes during the screening process 6. Sedentary - less than 150 minutes per week of structured moderate or vigorous physical activity. 7. No terminal or rapidly progressing illness, or condition that precludes participation in progressive resistance training
Exclusion criteria
Type 2 diabetes or use of oral hypoglycaemic medication or insulin Suicide ideation Illegal drug use Alcohol dependence/abuse (3 or 4 on CAGE questionnaire) Substance abuse disorder
Outcome results
None listed