Low-intensity Exercise in Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Obesity, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Low-intensity, general-fitness exercises
Psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome focused on measuring metabolic syndrome, low-intensity exercise, mental health, depression, stress, physical activity, women
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.
Sites / Locations
- Foundation for Senior Citizen Activation SIWY DYM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Metabolic Syndrome
Non-Metabolic Syndrome
Arm Description
Elderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Elderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04346836
First Posted
April 9, 2020
Last Updated
April 14, 2020
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM
1. Study Identification
Unique Protocol Identification Number
NCT04346836
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2018 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Glucose Metabolism Disorders
Keywords
metabolic syndrome, low-intensity exercise, mental health, depression, stress, physical activity, women
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metabolic Syndrome
Arm Type
Experimental
Arm Description
Elderly women with Metabolic Syndrome
24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Arm Title
Non-Metabolic Syndrome
Arm Type
Experimental
Arm Description
Elderly women without Metabolic Syndrome.
24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Low-intensity, general-fitness exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.
Primary Outcome Measure Information:
Title
Change in depression level from baseline
Description
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
Time Frame
At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
Secondary Outcome Measure Information:
Title
Change in perception of stress from baseline
Description
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.
Time Frame
At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, Prof.
Organizational Affiliation
University School of Physical Education in Wroclaw, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Foundation for Senior Citizen Activation SIWY DYM
City
Wrocław
State/Province
Lower Silesia
ZIP/Postal Code
50-240
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16681555
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.
Results Reference
background
PubMed Identifier
25470398
Citation
Archer T, Josefsson T, Lindwall M. Effects of physical exercise on depressive symptoms and biomarkers in depression. CNS Neurol Disord Drug Targets. 2014;13(10):1640-53. doi: 10.2174/1871527313666141130203245.
Results Reference
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PubMed Identifier
21570493
Citation
Baert V, Gorus E, Mets T, Geerts C, Bautmans I. Motivators and barriers for physical activity in the oldest old: a systematic review. Ageing Res Rev. 2011 Sep;10(4):464-74. doi: 10.1016/j.arr.2011.04.001. Epub 2011 May 5.
Results Reference
background
PubMed Identifier
17895733
Citation
Greenberg SA. How to try this: the Geriatric Depression Scale: Short Form. Am J Nurs. 2007 Oct;107(10):60-9; quiz 69-70. doi: 10.1097/01.NAJ.0000292204.52313.f3.
Results Reference
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PubMed Identifier
28503402
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.
Results Reference
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PubMed Identifier
28871311
Citation
Holzel LP, Harter M, Hull M. [Multiprofessional outpatient psychosocial treatment for elderly patients with mental disorders]. Nervenarzt. 2017 Nov;88(11):1227-1233. doi: 10.1007/s00115-017-0407-y. German.
Results Reference
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PubMed Identifier
21857330
Citation
Hsieh PL. A school-based health promotion program for stressed nursing students in Taiwan. J Nurs Res. 2011 Sep;19(3):230-7. doi: 10.1097/JNR.0b013e318228d010.
Results Reference
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Low-intensity Exercise in Metabolic Syndrome
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