Clinical trial NCT04346836: Low-intensity Exercise in Metabolic Syndrome
Official title: Low-intensity Exercise as a Predictor of Mental Health in Women With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Hypertension
Hyperlipidemias
Glucose Metabolism Disorders
Keywords: metabolic syndrome
low-intensity exercise
mental health
depression
stress
physical activity
women
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Foundation for Senior Citizen Activation SIWY DYM
First posted: 2020-04-15
Enrollment: 88
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in depression level from baseline
timeFrame: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
Secondary outcomes:
measure: Change in perception of stress from baseline
timeFrame: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Foundation for Senior Citizen Activation SIWY DYM
state: Lower Silesia
Study officials:
affiliation: University School of Physical Education in Wroclaw, Poland
name: Joanna Szczepańska-Gieracha, Prof.
role: STUDY_CHAIR
References:
citation: Alberti KG, Zimmet P, Shaw J. Metabolic syndrome--a new world-wide definition. A Consensus Statement from the International Diabetes Federation. Diabet Med. 2006 May;23(5):469-80. doi: 10.1111/j.1464-5491.2006.01858.x.
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citation: Hearing CM, Chang WC, Szuhany KL, Deckersbach T, Nierenberg AA, Sylvia LG. Physical Exercise for Treatment of Mood Disorders: A Critical Review. Curr Behav Neurosci Rep. 2016 Dec;3(4):350-359. doi: 10.1007/s40473-016-0089-y. Epub 2016 Oct 14.
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