Low-intensity Exercise in Metabolic Syndrome

Study Overview
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Brief Summary
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People with metabolic syndrome (MetS) are characterized by a lower quality of life in terms of reduced vital activity, emotional state, and social functioning. Therefore, the investigator's aim was to determine the impact of low-intensity exercise and psychoeducation on depression symptoms and self-perceived stress in women with MetS.

Detailed Description
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Metabolic syndrome (MetS) is currently one of the major threats to health in highly developed societies. A recent study has demonstrated that depression may be significantly associated with MetS in people aged 60 years or over. The more components of MetS that are evident in the individual, the more depressive symptoms this individual is likely to exhibit. MetS treatment is essentially founded on implementing lifestyle changes which involve regular physical activity and healthy dietary habits. Systematically undertaking exercise has a beneficial influence on health, particularly on cardiovascular system functions as well as the quality of life and depression status in middle-aged and older women with MetS. Previous work has shown moderate or high intensity exercise to be optimal for the treatment of MetS. Nevertheless, many patients with MetS have hypertension and obesity. Therefore, for safety reasons, the patient's condition during intensive group exercises should be constantly monitored by a physician or specialized equipment, which generates costs and may limit the availability of this type of intervention. Hence, the investigator's aim was to determine the impact of 12 weeks of low-intensity exercise, combined with psychoeducation, on the severity of depression symptoms and self-perceived stress in women with MetS.

Official Title
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Low-intensity Exercise as a Predictor of Mental Health in Women With Metabolic Syndrome

Conditions
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Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Glucose Metabolism Disorders

Intervention / Treatment
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* Behavioral: Low-intensity, general-fitness exercises
* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of Metabolic Syndrome diagnosed using the International Diabetes Federation-recommended criteria (2006): mandatory central obesity (defined as waist circumference ≥ 80 cm in females), and any two of the following: raised triglycerides (>150 mg/dL), reduced HDL cholesterol (50 mg/dL in females), elevated blood pressure (BP; systolic BP > 130 or diastolic BP > 85 mm Hg) , increased fasting plasma glucose (>100 mg/dL), Exclusion Criteria: disturbed cognitive functions (Mini-Mental State Examination > 23), the inability to move independently or a motor disability precluding exercise, serious neurological or orthopaedic conditions (e.g., advanced Parkinson's disease, severe stroke consequences), attending fewer than 13 intervention sessions.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metabolic Syndrome<br>Elderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. | Behavioral: Low-intensity, general-fitness exercises<br>* 24 session of low-intensity, general-fitness exercises (12 weeks, twice a week) A single session of exercise lasted 40 minutes and consisted of 42 low-intensity, general-fitness exercises. Perception of effort was monitored using the Borg 6-20 rating the perceived exertion (RPE). Thirty-three exercises were done sitting down, seven standing, and two in the hand-and-knees position. The exercises were classified as either aerobic, musculo-articular, or stabilising. The aerobic portion served as a general warm-up for the subsequent exercises, and the musculo-articular section focused on strengthening muscles and enhancing the mobility of joints in the upper limbs, the lower limbs and the torso. Stabilising exercises were designed to improve the stability of the body and to augment spatio-visual coordination.<br>Behavioral: Psychoeducation<br>* A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.<br>|
| Experimental: Non-Metabolic Syndrome<br>Elderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. | Behavioral: Low-intensity, general-fitness exercises<br>* 24 session of low-intensity, general-fitness exercises (12 weeks, twice a week) A single session of exercise lasted 40 minutes and consisted of 42 low-intensity, general-fitness exercises. Perception of effort was monitored using the Borg 6-20 rating the perceived exertion (RPE). Thirty-three exercises were done sitting down, seven standing, and two in the hand-and-knees position. The exercises were classified as either aerobic, musculo-articular, or stabilising. The aerobic portion served as a general warm-up for the subsequent exercises, and the musculo-articular section focused on strengthening muscles and enhancing the mobility of joints in the upper limbs, the lower limbs and the torso. Stabilising exercises were designed to improve the stability of the body and to augment spatio-visual coordination.<br>Behavioral: Psychoeducation<br>* A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression level from baseline | As a primary outcome measure, the Geriatric Depression Scale (GDS) was used. GDS is a self-report 15-items measure of well-being and mood in older adults. The patient responds in a Yes/No format. Scoring ranges from 0 to 15. A score greater than 5 points is suggestive of depression, and 10 points or more is almost always indicative of depression. With the sensitivity standing at 92%, the GDS is useful in the diagnosis of late-life depression in primary care | At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perception of stress from baseline | As a secondary outcome measure, the Perception of Stress Questionnaire (PSQ) was used. PSQ is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment. | At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, low-intensity exercise, mental health, depression, stress, physical activity, women