CClinicalTrials.gg
CompletedNCT04346836Updated Apr 15, 2020

Low-intensity Exercise in Metabolic Syndrome

An interventional study of Low-intensity, general-fitness exercises and Psychoeducation in Metabolic Syndrome, Obesity and Hypertension, sponsored by Wroclaw University of Health and Sport Sciences. Completed at 1 site in Poland. Open to female participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-15.

Sponsored by Wroclaw University of Health and Sport Sciences · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled May 2018, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Non-randomized
Ages
60 Years to 85 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • metabolic syndrome
  • low-intensity exercise
  • mental health
  • depression
  • stress
  • physical activity
  • women
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 88 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Wroclaw University of Health and Sport Sciences is the lead sponsor of 44 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Metabolic Syndrome

    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

  • Experimental
    Non-Metabolic Syndrome

    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

  • BehavioralLow-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.

  • BehavioralPsychoeducation

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

06

What researchers measure

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

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

Secondary outcomes

  1. Change in perception of stress from baseline

    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.

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

07

Study locations

1 site
  • Foundation for Senior Citizen Activation SIWY DYM
    Wrocław, Lower Silesia 50-240, Poland
08

References and documents

Publications

  • 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. PubMed 16681555 ↗
  • 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. PubMed 25470398 ↗
  • 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. PubMed 21570493 ↗
  • 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. PubMed 17895733 ↗
  • 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. PubMed 28503402 ↗
  • 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. PubMed 28871311 ↗
  • 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. PubMed 21857330 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04346836
Lead sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM
Responsible party
Joanna Szczepańska-Gieracha (Professor, Wroclaw University of Health and Sport Sciences) — Principal investigator
First posted
Apr 15, 2020
Start date
May 6, 2018
Primary completion
May 10, 2019
Completion
Jan 10, 2020
Last update
Apr 15, 2020

Study contacts

Joanna Szczepańska-Gieracha, Prof.
study chair · University School of Physical Education in Wroclaw, Poland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion