Exercise, Insulin Resistance, and Chronic Pain in Postmenopausal Women.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSão Paulo State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Combined Exercise Program
BehavioralParticipants 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 Group
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 2 interventions
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame
Baseline and at 12 months following interventionSecondary outcomes
1
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.
Time frame
Baseline (pre-intervention) and after 12 months of intervention2
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.
Time frame
Baseline and after 12 months of intervention3
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.
Time frame
Baseline and after 12 months of intervention4
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.
Time frame
Baseline and after 12 months of interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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