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Low-intensity Exercise in Metabolic Syndrome

2020년 4월 14일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

88

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

60년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Metabolic Syndrome

Elderly women with Metabolic Syndrome

24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
행동: 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.

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

Elderly women without Metabolic Syndrome.

24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.
행동: 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.

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in depression level from baseline
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in perception of stress from baseline
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University School of Physical Education in Wroclaw

협력자

Foundation for Senior Citizen Activation SIWY DYM

수사관

  • 연구 의자: Joanna Szczepańska-Gieracha, Prof., University School of Physical Education in Wroclaw, Poland

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 5월 6일

기본 완료 (실제)

2019년 5월 10일

연구 완료 (실제)

2020년 1월 10일

연구 등록 날짜

최초 제출

2020년 4월 9일

QC 기준을 충족하는 최초 제출

2020년 4월 14일

처음 게시됨 (실제)

2020년 4월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 4월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 4월 14일

마지막으로 확인됨

2020년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 59/0203/S/04

개별 참가자 데이터(IPD) 계획

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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