- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04346836
Low-intensity Exercise in Metabolic Syndrome
Low-intensity Exercise as a Predictor of Mental Health in Women With Metabolic Syndrome
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Lower Silesia
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Wrocław, Lower Silesia, Polsko, 50-240
- Foundation for Senior Citizen Activation SIWY DYM
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Metabolic Syndrome
Elderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. |
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.
A psychoeducation provided by psychotherapist.
Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.
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Experimentální: Non-Metabolic Syndrome
Elderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. |
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.
A psychoeducation provided by psychotherapist.
Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in depression level from baseline
Časové okno: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
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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
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At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in perception of stress from baseline
Časové okno: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
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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.
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At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Joanna Szczepańska-Gieracha, Prof., University School of Physical Education in Wroclaw, Poland
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
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Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 59/0203/S/04
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