The MUSE Study for Menopausal Arthralgia
NCT Number: NCT06530459
Acronym: MUSE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Arthralgia|Menopause|Perimenopausal Disorder|Joint Pain|Postmenopausal Disorder
Interventions: DRUG: Menopausal hormone therapy|BEHAVIORAL: Exercise training|COMBINATION_PRODUCT: Menopausal hormone therapy + exercise training
Sponsor: National University Hospital, Singapore
Sex: FEMALE
Age: ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-04
Locations: National University Hospital, Singapore, Singapore

Summary:
The investigators plan to conduct a pilot 4-arm, randomized study comprising the following interventions: muscle strengthening exercises (MSE) alone, estrogen therapy (ET) alone, and a combination of MSE and ET, compared to usual care in women with menopausal arthralgia. The aim of this pilot study is to assess the feasibility, patient acceptability, and patient perspectives and logistics of delivering interventions, and practicability of outcome assessment tools in this 4-arm study over a 12-week period.

Primary Outcome Measures: Relative changes in perceived arthralgia at the end of intervention, Relative changes in perceived arthralgia with the 10-item Örebro Musculoskeletal Pain Screening Questionnaire (Short Form) would be the pre-specified primary outcome parameter.

Participants would be asked to rank each item on a 11-point scale from 0 to 10., After 12 weeks of intervention
Secondary Outcome Measures: Changes in Handgrip strength (kg), Handgrip strength (kg) will be assessed twice on each arm, using the Jamar dynamometer., After 12 weeks of intervention|Changes in isokinetic knee extension strength (degree/second), The knee extension strength test will be conducted using the isokinetic dynamometry with Biodex, and measured in degree/second., After 12 weeks of intervention|Changes in physical performance using the Physical Performance Battery, The investigators will use a modified version of the lower-extremity performance tests conducted in the Established Populations for the Epidemiologic Studies of the Elderly, wherein scores from four tests will be added to form a continuous score ranging from 0 to 4., After 12 weeks of intervention|Changes in associated menopausal symptoms using the Menopause Rating Scale (MRS), Menopausal symptoms will be assessed using the Menopause Rating Scale (MRS), comprising 11 menopausal symptoms. Each symptom will be scored from 0-4 (none, mild, moderate, severe, and extremely severe)., After 12 weeks of intervention|Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI), The Pittsburgh Sleep Quality Index will be used to assess perceived sleep habits in the past month, with a maximum score of 21 points., After 12 weeks of intervention|Changes in anxiety symptoms using the GAD-7, Anxiety symptoms will be assessed by the General Anxiety Disorder Scale (GAD-7), and scoring ranges from 0 to 21 points., After 12 weeks of intervention|Changes in depression symptoms using the CES-D, Depressive symptoms will be assessed using the Center for Epidemiologic Studies for Depression Scale (CES-D). The maximum score is 60., After 12 weeks of intervention|Changes in perceived quality of life using the SF-12., The 12-Item Short Form Survey (SF-12) will be used to assess quality of life., After 12 weeks of intervention|Changes in verbal memory measured using the Hopkins Verbal Learning Test, The Hopkins Verbal Learning Test will be used to assess delays in recall and retention of 12 words., After 12 weeks of intervention|Changes in insulin resistance using HOMA-IR, Fasting blood glucose and insulin will be measured to obtain the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)., After 12 weeks of intervention