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The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Combination product, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 59
Healthy Volunteers: t
View:

• Patients with muscle stiffness and joint discomfort in various sites, including hands, knees, back, hips, and/or shoulders. Patients with pain in only one isolated joint would not be accepted.

• Arthralgia symptoms with onset, or has become worse, over the perimenopausal or early postmenopausal period (within 5 years of the menopause).

• Women should be at the menopause transition, less than or equal to 59 years old at the time of enrollment, or within 5 years of menopause whichever is earlier.

• .

• Arthralgia for at least 3 months (pain lasting beyond normal injury healing period)

• Community-dwelling and able to ambulate independently.

Locations
Other Locations
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
Eu-Leong Yong, PhD
obgyel@nus.edu.sg
67724278
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2028-04
Participants
Target number of participants: 100
Treatments
Experimental: Exercise
Curated exercises designed to address specific muscle groups and joints that are painful and problematic.~Exercises would focus on upper and lower body strength generally. It is anticipated that participants ideally should exercise at least 3 times per week based on the strength training prescription. They could potentially exercise everyday, alternating between upper and lower body strength training.
Experimental: Menopausal hormone therapy
Menopausal hormone therapy comprising: 17beta-estradiol topical gel (1.25-2.5 gms) applied daily, and micronized Progesterone 200mg daily for 12 days each month.
Experimental: Combination of exercise and menopausal hormone therapy
1. Curated exercises designed to address specific muscle groups and joints that are painful and problematic.~ Exercises would focus on upper and lower body strength generally. It is anticipated that the participants ideally should exercise at least 3 times per week based on the strength training prescription. They could potentially exercise everyday, alternating between upper and lower body strength training.~2. Menopausal hormone therapy comprising: 17beta-estradiol topical gel (1.25-2.5 gms) applied daily, and micronized Progesterone 200mg daily for 12 days each month.
No_intervention: Standard care
Standard care will be provided.
Related Therapeutic Areas
Sponsors
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov