Impact of a yoga intervention over 6, 12, and 24 months in sedentary climacteric women with metabolic syndrome
| ISRCTN | ISRCTN86106594 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86106594 |
- Submission date
- 29/10/2025
- Registration date
- 30/10/2025
- Last edited
- 30/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Metabolic syndrome is a condition that increases the risk of diabetes and heart disease and is common in women during menopause. Yoga may help improve both physical and emotional health during this period. This study aims to evaluate the effects of a structured Shivam Yoga training program over 6, 12, and 24 months on the prevalence of metabolic syndrome (MetS) and climacteric symptoms in sedentary women.
Who can participate?
Sedentary women aged 40–65 years who meet the diagnostic criteria for metabolic syndrome.
What does the study involve?
Participants are randomly assigned to either a yoga group or a control group. The yoga group attends two 60-minute Shivam Yoga sessions per week, including breathing exercises, physical postures, relaxation, and meditation, for a total duration of 24 months. The control group continues their usual lifestyle without structured exercise. All participants attend follow-up assessments at 6, 12, and 24 months, including interviews, blood tests, and physical measurements.
What are the possible benefits and risks of participating?
Yoga may help reduce blood pressure, blood glucose, and waist circumference and may improve mood and sleep. The intervention is low-impact and generally safe, although mild muscle soreness may occur at the beginning of practice.
Where is the study run from?
The study is conducted at the Federal University of Ouro Preto (UFOP), Minas Gerais, Brazil.
When is the study starting and how long is it expected to run for?
The study started in October 2018 and was completed in 2021.
Who is funding the study?
The study is funded by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES, Finance Code 001), which provided a scholarship for the first author, and by the Fundação de Amparo à Pesquisa do Estado de Minas Gerais (FAPEMIG, BDP 00365-22).
Who is the main contact?
Dr Laura Alves Cota e Souza — Federal University of Ouro Preto (UFOP), Brazil
laura.cota@aluno.ufop.edu.br
Contact information
Public, Scientific, Principal investigator
Escola de Farmácia, Campus Universitário Morro do Cruzeiro
Ouro Preto
35.402-163
Brazil
 ORCID ID |
0000-0001-8625-6995 |
|---|---|
| laura.cota@aluno.ufop.edu.br |
Study information
| Study design | Single-centre interventional non-blinded randomized controlled longitudinal study with simple 1:1 allocation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, University/medical school/dental school |
| Study type | Efficacy, Prevention, Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Long-term effects of a structured Shivam Yoga intervention on symptoms, metabolic, and anthropometric parameters in sedentary climacteric women |
| Study acronym | SYCLIMET |
| Study objectives | To evaluate the long-term effects of regular Shivam Yoga practice on metabolic syndrome prevalence, anthropometric parameters, blood pressure, biochemical markers, and climacteric symptoms in sedentary women aged 40–65 years. |
| Ethics approval(s) |
Approved 15/10/2018, Research Ethics Committee of the Federal University of Ouro Preto (Campus Universitário Morro do Cruzeiro, Rua Cinco, s/n, Centro de Convergência, Ground Floor, PROPPI Block, Room 1, Bauxita District, Ouro Preto, 35402-163, Brazil; -; cep.propp@ufop.edu.br), ref: 95824318.2.0000.5150 |
| Health condition(s) or problem(s) studied | Metabolic syndrome and climacteric symptoms in sedentary middle-aged women. |
| Intervention | Participants are randomly assigned 1:1 to a yoga intervention or control group. The yoga group attends twice-weekly 60-minute Shivam Yoga sessions (postures, breathing, relaxation, meditation) for 24 months. The control group maintains their usual lifestyle without structured exercise. Assessments occur at 6, 12, and 24 months. Randomisation was performed using a computer-generated random sequence in Microsoft Excel, with simple randomisation and no restrictions. |
| Intervention type | Behavioural |
| Primary outcome measure | Prevalence of metabolic syndrome measured using Joint Interim Statement (JIS) diagnostic criteria at baseline, 6, 12, and 24 months. |
| Secondary outcome measures | 1. Fasting glucose, triglycerides, and HDL cholesterol measured using enzymatic spectrophotometric assays at baseline, 6, 12, and 24 months 2. Waist circumference measured using a standard tape at the midpoint between the lower rib and iliac crest at baseline, 6, 12, and 24 months 3. Systolic and diastolic blood pressure measured using a digital wrist sphygmomanometer (Bioland® - 3005) at baseline, 6, 12, and 24 months 4. Climacteric symptoms measured using the Kupperman Index questionnaire at baseline, 6, 12, and 24 months |
| Overall study start date | 15/10/2018 |
| Completion date | 30/12/2022 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 102 |
| Total final enrolment | 57 |
| Key inclusion criteria | 1. Women aged 40–65 years. 2. Diagnosed with metabolic syndrome according to the Joint Interim Statement (JIS) criteria. 3. Sedentary lifestyle (no regular physical activity in the previous 6 months). 4. Willingness to participate and provide written informed consent. |
| Key exclusion criteria | Women reporting significant lifestyle changes, initiation of exercise programs, or new medication use were excluded from the analysis. |
| Date of first enrolment | 01/11/2018 |
| Date of final enrolment | 02/09/2021 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Ouro Preto
35.402-163
Brazil
Sponsor information
University/education
Campus Universitário Morro do Cruzeiro, Bairro Bauxita
Ouro Preto
35.402-163
Brazil
| propp@ufop.edu.br | |
| Website | https://ufop.br/ |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 30/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Study findings are planned for publication in peer-reviewed journals and dissemination through academic conferences. The main manuscript, titled “Impact of a Yoga Intervention Over 6, 12, and 24 Months in Sedentary Climacteric Women with Metabolic Syndrome,” is currently under final revision for publication. Additional papers exploring hormonal and molecular outcomes are being prepared. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon reasonable request to the corresponding author (Dr Laura Alves Cota e Souza, laura.cota@aluno.ufop.edu.br) and after approval by the Research Ethics Committee of the Federal University of Ouro Preto. Only de-identified data will be shared, including anthropometric, biochemical, and questionnaire results. Data will be made available for research purposes only, upon submission of a brief proposal describing the intended use and analysis plan. Participant consent covered the use of anonymized data for secondary analyses. No personal identifiers will be shared. |
Editorial Notes
30/10/2025: Trial's existence confirmed by Research Ethics Committee of the Federal University of Ouro Preto.
