Chronic PainEX-PAIN-MENONCT07407699
Exercise, Insulin Resistance, and Chronic Pain in Postmenopausal Women.
A study testing Combined Exercise Program in people with Chronic Pain and Postmenopausal, run by São Paulo State University.
Trial summary
This study aims to investigate the effects of a combined exercise program on chronic pain in postmenopausal women, considering insulin resistance as a potential physiological mediator. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chronic Pain, Postmenopausal, Insulin Resistance
- What is being tested?
- Combined Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women, defined as between 12 months and 5 years since the last menstrual period.
- Not using hormone replacement therapy.
- Not engaged in regular physical exercise (defined as more than once per week in the last months).
- With or without insulin resistance.
Who cannot join
- Diagnosis of neurological diseases (e.g., Parkinson's disease, multiple sclerosis, or stroke sequelae).
- Severe psychiatric disorders.
- Inflammatory autoimmune diseases (e.g., rheumatoid arthritis or systemic lupus erythematosus).
- Active neoplasms.
- Use of systemic corticosteroids or immunosuppressive drugs within the last three months.
- Severe decompensated cardiovascular disease.
- Any medical condition that contraindicates participation in physical exercise.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Isulin Resistance as a Mediator of Chronic Pain in Postmenopausal Women: Effects of a Combined Exercise Program on Metabolic and Inflammatory Mechanisms
This study aims to investigate the effects of a combined exercise program on chronic pain in postmenopausal women, considering insulin resistance as a potential physiological mediator. The intervention will assess changes in pain intensity, metabolic and inflammatory biomarkers, psychosocial factors, and body composition. The findings may contribute to understanding the metabolic mechanisms underlying chronic pain in postmenopausal women and support exercise as a non-pharmacological therapeutic strategy.
Read the detailed description
Postmenopausal women experience a high prevalence of chronic musculoskeletal pain, potentially influenced by hormonal depletion, metabolic dysfunction, and low-grade systemic inflammation. Insulin resistance has been associated with inflammatory processes and may contribute to peripheral and central sensitization mechanisms involved in chronic pain.
This randomized controlled trial will evaluate the effects of a combined exercise intervention, including aerobic, resistance, and mind-body components, on pain intensity and related outcomes in postmenopausal women with chronic pain. Secondary outcomes include metabolic markers, inflammatory biomarkers, psychosocial variables, and body composition. Insulin resistance will be explored as a mediator of pain modulation following the exercise intervention.
- Conditions
- Chronic Pain, Postmenopausal, Insulin Resistance
- Being tested
- Combined Exercise Program, Usual Care Group
- Medical subject headings
- Chronic Pain, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Exercise ProgramBehavioural
Participants allocated to the intervention group will take part in a supervised combined exercise program, performed twice weekly for 12 months. Each session will last approximately 60 minutes and will include aerobic exercise, resistance training, and mind-body exercise.
Aerobic training will consist of walking or cycling at moderate intensity, monitored by heart rate. Resistance training will involve multi-joint exercises using body weight and elastic bands, with progressive overload. Mind-body exercise will be performed using restorative yoga techniques. Exercise sessions will be supervised by a trained physiotherapist.
Usual Care GroupOther
Participants allocated to the control group will continue with their usual care and daily activities, without participation in any structured or supervised exercise program during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Postmenopausal women undergoing a supervised combined exercise program (aerobic, resistance, and mind-body exercise). Receives: Behavioral: Combined Exercise Program; Other: Usual Care Group |
| Control Group | No intervention | Postmenopausal women who will continue receiving usual care without participation in a structured exercise program during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline and at 12 months following intervention
Secondary outcomes (11)
Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance will be evaluated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin levels.
Measured: Baseline (pre-intervention) and after 12 months of intervention
Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
Anxiety symptoms will be assessed using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.
Measured: Baseline and after 12 months of intervention
Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D), ranging from 0 to 21, with higher scores indicating greater depressive symptoms.
Measured: Baseline and after 12 months of intervention
Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), ranging from 0 to 52, with higher scores indicating greater catastrophizing.
Measured: Baseline and after 12 months of intervention
Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Self-efficacy related to pain management will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ), ranging from 0 to 60, with higher scores indicating greater self-efficacy.
Measured: Baseline and after 12 months of intervention
Quality of life assessed by Short Form Health Survey (SF-36)
Quality of life will be assessed using the Short Form Health Survey (SF-36), with scores ranging from 0 to 100, where higher scores indicate better health-related quality of life.
Measured: Baseline and after 12 months of intervention
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline and after 12 months of intervention
Body weight
Body weight will be measured using a calibrated scale and expressed in kilograms (kg).
Measured: Baseline and after 12 months of intervention
Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA)
Body fat percentage will be assessed using dual-energy X-ray absorptiometry (DEXA). Values will be expressed as percentage (%), with higher values indicating greater body fat.
Measured: Baseline and after 12 months of intervention
Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA)
Total fat mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and expressed in kilograms (kg).
Measured: Baseline and after 12 months of intervention
Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA)
Total lean mass will be assessed using dual-energy X-ray absorptiometry (DEXA) and expressed in kilograms (kg). Higher values indicate greater lean mass.
Measured: Baseline and after 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Carrion Caldeira Ribeiro, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407699
- Sponsor's protocol ID
- DOUTORADO_FCT_UNESP_2026
- Acronym
- EX-PAIN-MENO
- Status last verified
- Feb 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isulin Resistance as a Mediator of Chronic Pain in Postmenopausal Women: Effects of a Combined Exercise Program on Metabolic and Inflammatory Mechanisms
- ClinicalTrials.gov ID
- NCT07407699
- Acronym / sponsor ID
- EX-PAIN-MENO / DOUTORADO_FCT_UNESP_2026
- Conditions
- Chronic Pain, Postmenopausal, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
This study aims to investigate the effects of a combined exercise program on chronic pain in postmenopausal women, considering insulin resistance as a potential physiological mediator. The intervention will assess changes in pain intensity, metabolic and inflammatory biomarkers, psychosocial factors, and body composition. The findings may contribute to understanding the metabolic mechanisms underlying chronic pain in postmenopausal women and support exercise as a non-pharmacological therapeutic strategy.
Detailed description
Postmenopausal women experience a high prevalence of chronic musculoskeletal pain, potentially influenced by hormonal depletion, metabolic dysfunction, and low-grade systemic inflammation. Insulin resistance has been associated with inflammatory processes and may contribute to peripheral and central sensitization mechanisms involved in chronic pain.
This randomized controlled trial will evaluate the effects of a combined exercise intervention, including aerobic, resistance, and mind-body components, on pain intensity and related outcomes in postmenopausal women with chronic pain. Secondary outcomes include metabolic markers, inflammatory biomarkers, psychosocial variables, and body composition. Insulin resistance will be explored as a mediator of pain modulation following the exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Combined Exercise Program, Other: Usual Care GroupPostmenopausal women undergoing a supervised combined exercise program (aerobic, resistance, and mind-body exercise). |
| Control Group | No intervention | –Postmenopausal women who will continue receiving usual care without participation in a structured exercise program during the study period. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women, defined as between 12 months and 5 years since the last menstrual period.
- Not using hormone replacement therapy.
- Not engaged in regular physical exercise (defined as more than once per week in the last months).
- With or without insulin resistance.
Key exclusion criteria (7 listed)
- Diagnosis of neurological diseases (e.g., Parkinson's disease, multiple sclerosis, or stroke sequelae).
- Severe psychiatric disorders.
- Inflammatory autoimmune diseases (e.g., rheumatoid arthritis or systemic lupus erythematosus).
- Active neoplasms.
- Use of systemic corticosteroids or immunosuppressive drugs within the last three months.
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 |
|---|---|---|
| Combined Exercise ProgramParticipants allocated to the intervention group will take part in a supervised combined exercise program, performed twice weekly for 12 months. Each session will last approximately 60 minutes and will include aerobic exercise, resistance training, and mind-body exercise. Aerobic training will consist of walking or cycling at moderate intensity, monitored by heart rate. Resistance training will involve multi-joint exercises using body weight and elastic bands, with progressive overload. Mind-body exercise will be performed using restorative yoga techniques. Exercise sessions will be supervised by a trained physiotherapist. | Behavioural | Intervention group |
| Usual Care GroupParticipants allocated to the control group will continue with their usual care and daily activities, without participation in any structured or supervised exercise program during the study period. | Other | Intervention group |
Primary outcome
Pain Intensity
Time frame: Baseline and at 12 months following intervention
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain).
11 secondary outcomes
Insulin Resistance assessed by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline (pre-intervention) and after 12 months of intervention
Anxiety assessed by Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)
Time frame: Baseline and after 12 months of intervention
Depression assessed by Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time frame: Baseline and after 12 months of intervention
Pain catastrophizing assessed by Pain Catastrophizing Scale (PCS)
Time frame: Baseline and after 12 months of intervention
Pain self-efficacy assessed by Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Baseline and after 12 months of intervention
Quality of life assessed by Short Form Health Survey (SF-36)
Time frame: Baseline and after 12 months of intervention
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and after 12 months of intervention
Body weight
Time frame: Baseline and after 12 months of intervention
Body fat percentage assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame: Baseline and after 12 months of intervention
Total fat mass assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame: Baseline and after 12 months of intervention
Total lean mass assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame: Baseline and after 12 months of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercise Program in people with Chronic Pain and Postmenopausal, run by São Paulo State University.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Ribeiro (55+18996921106, gabrielacarrion123@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and at 12 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.