Low-intensity Exercise in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders; Hyperlipidemias; Metabolic Syndrome; Obesity; Hypertension
• Interventions: Behavioral: Low-intensity, general-fitness exercises; Behavioral: Psychoeducation

• Registration Number: NCT04346836
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-06
• Primary Completion: 2019-05-10
• Study Completion: 2020-01-10
• Status Verified: 2020-04
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Metabolic Syndrome	Psychoeducation	Elderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Non-Metabolic Syndrome	Low-intensity, general-fitness exercises	Elderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Metabolic Syndrome	Low-intensity, general-fitness exercises	Elderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Metabolic Syndrome	Psychoeducation	Elderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in depression level from baseline	At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)	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

Secondary Outcome Measures

Name	Time	Method
Change in perception of stress from baseline	At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)	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.

Trial Locations

Locations (1)

Foundation for Senior Citizen Activation SIWY DYM; 🇵🇱 Wrocław, Lower Silesia, Poland