Metabolic SyndromeNCT04346836
Low-intensity Exercise in Metabolic Syndrome
A study testing Low-intensity, general-fitness exercises and Psychoeducation in people with Metabolic Syndrome and Obesity, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Hypertension
- What is being tested?
- Low-intensity, general-fitness exercises and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePoland
- Study dates
- 6 May 2018to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Foundation for Senior Citizen Activation SIWY DYM
Wroclaw, Lower Silesian Voivodeship, 50-240
About this study
Official title: 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.
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.
- Being tested
- Low-intensity, general-fitness exercises, Psychoeducation
- Keywords
- metabolic syndrome, low-intensity exercise, mental health, depression, stress, physical activity, women
- Medical subject headings
- Metabolic Syndrome, Obesity, Hypertension, Hyperlipidemias, Glucose Metabolism Disorders, Psychological Well-Being, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity, general-fitness exercisesBehavioural
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.
PsychoeducationBehavioural
A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Syndrome | Experimental | Elderly women with Metabolic Syndrome
24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. Receives: 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. Receives: Behavioral: Low-intensity, general-fitness exercises; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start6 May 2018
- Primary completion10 May 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Senior Citizen Activation SIWY DYM
- Responsible party
- Principal investigator, Joanna Szczepańska-Gieracha, Wroclaw University of Health and Sport Sciences
- Investigators
- Joanna Szczepańska-Gieracha, Prof., Study chair, University School of Physical Education in Wroclaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346836
- Sponsor's protocol ID
- 59/0203/S/04
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16681555Archer 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 25470398Baert 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 21570493Greenberg 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 17895733Hearing 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 28503402Holzel 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 28871311Hsieh 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-intensity Exercise as a Predictor of Mental Health in Women With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04346836
- Acronym / sponsor ID
- 59/0203/S/04
- Keywords
- metabolic syndrome, low-intensity exercise, mental health, depression, stress, physical activity, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Foundation for Senior Citizen Activation SIWY DYM
- Study start
- 6 May 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic Syndrome | Experimental | Behavioral: Low-intensity, general-fitness exercises, Behavioral: PsychoeducationElderly women with Metabolic Syndrome 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. |
| Non-Metabolic Syndrome | Experimental | Behavioral: Low-intensity, general-fitness exercises, Behavioral: PsychoeducationElderly women without Metabolic Syndrome. 24 sessions of low-intensity exercise and psychoeducation, twice a week over 12 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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),
- 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) ,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity, general-fitness exercises24 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. | Behavioural | Metabolic Syndrome, Non-Metabolic Syndrome |
| PsychoeducationA psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits. | Behavioural | Metabolic Syndrome, Non-Metabolic Syndrome |
Primary outcome
Change in depression level from baseline
Time frame: 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
1 secondary outcome
Change in perception of stress from baseline
Time frame: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Background: PubMed 16681555Alberti 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.
- Background: PubMed 25470398Archer 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.
- Background: PubMed 21570493Baert 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.
- Background: PubMed 17895733Greenberg 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.
- Background: PubMed 28503402Hearing 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.
- Background: PubMed 28871311Holzel 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.
- Background: PubMed 21857330Hsieh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Szczepańska-Gieracha, Prof. study chair
University School of Physical Education in Wroclaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity, general-fitness exercises and Psychoeducation in people with Metabolic Syndrome and Obesity, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression level from baseline (time frame: At baseline and after 24 sessions of low-intensity exercise and psychoeducation (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346836, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.