Low-intensity Exercise in Metabolic Syndrome

NCT ID: NCT04346836

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-06

Study Completion Date

2020-01-10

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Obesity Hypertension Hyperlipidemias Glucose Metabolism Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Metabolic Syndrome

Elderly women with Metabolic Syndrome

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

Group Type EXPERIMENTAL

Low-intensity, general-fitness exercises

Intervention Type BEHAVIORAL

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.

Psychoeducation

Intervention Type BEHAVIORAL

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

Non-Metabolic Syndrome

Elderly women without Metabolic Syndrome.

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

Group Type EXPERIMENTAL

Low-intensity, general-fitness exercises

Intervention Type BEHAVIORAL

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.

Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Foundation for Senior Citizen Activation SIWY DYM

OTHER

Sponsor Role collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role lead

Responsible Party

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Joanna Szczepańska-Gieracha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanna Szczepańska-Gieracha, Prof.

Role: STUDY_CHAIR

University School of Physical Education in Wroclaw, Poland

Locations

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Foundation for Senior Citizen Activation SIWY DYM

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 16681555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25470398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21570493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17895733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28503402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28871311 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21857330 (View on PubMed)

Other Identifiers

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59/0203/S/04

Identifier Type: -

Identifier Source: org_study_id

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