Low-intensity Exercise in Metabolic Syndrome

NCT04346836 | Completed

• 1 other identifier: 59/0203/S/04
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Obesity; Hypertension; Hyperlipidemias; Glucose Metabolism Disorders

Keywords

metabolic syndrome; low-intensity exercise; mental health; depression; stress; physical activity; women

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)

Secondary Outcomes (1)

• Change in perception of stress from baseline

  At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)

Study Arms (2)

Metabolic Syndrome

EXPERIMENTAL

Elderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.

Behavioral: Low-intensity, general-fitness exercises; Behavioral: Psychoeducation

Non-Metabolic Syndrome

EXPERIMENTAL

Elderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks.

Behavioral: Low-intensity, general-fitness exercises; Behavioral: Psychoeducation

Interventions

Low-intensity, general-fitness exercises 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.

Metabolic Syndrome; Non-Metabolic Syndrome

Psychoeducation BEHAVIORAL

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

Metabolic Syndrome; Non-Metabolic Syndrome

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Foundation for Senior Citizen Activation SIWY DYM: collaborator

Study Sites (1)

Foundation for Senior Citizen Activation SIWY DYM

Wroclaw, Lower Silesian Voivodeship, 50-240, Poland

Location

Related Publications (7)

• 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.

  PMID: 16681555 BACKGROUND

• 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.

  PMID: 25470398 BACKGROUND

• 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.

  PMID: 21570493 BACKGROUND

• 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.

  PMID: 17895733 BACKGROUND

• 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.

  PMID: 28503402 BACKGROUND

• 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.

  PMID: 28871311 BACKGROUND

• 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.

  PMID: 21857330 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Hypertension; Hyperlipidemias; Glucose Metabolism Disorders; Psychological Well-Being; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Personal Satisfaction; Behavior; Behavioral Symptoms

Study Officials

• Joanna Szczepańska-Gieracha, Prof.

  University School of Physical Education in Wroclaw, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 15, 2020
• Study Start: May 6, 2018
• Primary Completion: May 10, 2019
• Study Completion: January 10, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)