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Completed

NCT Number: NCT04346836

Low-intensity Exercise in Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Behavior Behavioral Symptoms Body Weight Cardiovascular Diseases Depression Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Vascular Diseases

Age range

60 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Foundation for Senior Citizen Activation SIWY DYM

Wroclaw, Lower Silesian Voivodeship, 50-240, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-intensity, general-fitness exercises

Behavioral

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.

Psychoeducation

Behavioral

A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.

Primary outcomes

  1. Change in depression level from baseline

    Time frame: 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 outcomes

  1. Change in perception of stress from baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Collaborators

  • Foundation for Senior Citizen Activation SIWY DYM

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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