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Low-intensity Exercise in Metabolic Syndrome

14 aprile 2020 aggiornato da: Joanna Szczepańska-Gieracha, University School of Physical Education in Wroclaw

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

88

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Polonia
    • Lower Silesia
      • Wrocław, Lower Silesia, Polonia, 50-240
        • Foundation for Senior Citizen Activation SIWY DYM

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 60 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Metabolic Syndrome

Elderly women with Metabolic Syndrome

24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Comportamentale: Low-intensity, general-fitness exercises

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.

Comportamentale: Psychoeducation
A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.
Sperimentale: Non-Metabolic Syndrome

Elderly women without Metabolic Syndrome.

24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
Comportamentale: Low-intensity, general-fitness exercises

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.

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in depression level from baseline
Lasso di tempo: 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
At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in perception of stress from baseline
Lasso di tempo: 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.
At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University School of Physical Education in Wroclaw

Collaboratori

Foundation for Senior Citizen Activation SIWY DYM

Investigatori

  • Cattedra di studio: Joanna Szczepańska-Gieracha, Prof., University School of Physical Education in Wroclaw, Poland

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 maggio 2018

Completamento primario (Effettivo)

10 maggio 2019

Completamento dello studio (Effettivo)

10 gennaio 2020

Date di iscrizione allo studio

Primo inviato

9 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

14 aprile 2020

Primo Inserito (Effettivo)

15 aprile 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 aprile 2020

Ultimo verificato

1 aprile 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 59/0203/S/04

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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