Actively Recruiting

Phase 2
Phase 3
Age: 30Years - 59Years
FEMALE
Healthy Volunteers
ID06530459

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

Led by National University Hospital, Singapore · Updated on 2024-07-31

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating muscle strengthening exercises (MSE), estrogen therapy (ET), and their combination compared to usual care in women experiencing menopausal arthralgia. This pilot randomized study aims to explore the feasibility, patient acceptance, and practicality of delivering these interventions and assessing outcomes over a 12-week period in women going through menopause or early postmenopause. Participants will be randomly assigned to one of four groups for 12 weeks: usual care, ET only, MSE only, or both MSE and ET. The ET group applies 17 beta-estradiol gel daily to affected joints and muscles, with micronized progesterone tablets taken orally for 12 days each month if the uterus is intact. The MSE group receives tailored upper and lower body strength exercises demonstrated by physiotherapists, encouraged at least three times weekly, possibly daily. The combination group follows both treatments simultaneously, while the usual care group continues their normal routines. Participants will undergo assessments at the start and after 12 weeks, including evaluations of joint pain, handgrip and knee strength, physical performance, menopausal symptoms, sleep quality, anxiety, depression, quality of life, verbal memory, and insulin resistance. Exercise adherence is supported by weekly reminders and social media posts. The study will monitor changes using validated scales and tests to understand the interventions' impact on menopausal joint discomfort and related symptoms.

CONDITIONS

Brief Title

The MUSE Study for Menopausal Arthralgia

Who Can Participate

Age: 30Years - 59Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with muscle stiffness and joint discomfort in multiple sites, such as hands, knees, back, hips, or shoulders
  • Arthralgia symptoms started or worsened during perimenopause or within 5 years after menopause
  • Women at menopause transition, aged up to 59 years or within 5 years of menopause, whichever is earlier
  • Joint pain lasting at least 3 months
  • Community-dwelling and able to walk independently
Not Eligible

You will not qualify if you...

  • History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia, psychiatric disorders, active liver disease, renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions
  • Pregnancy
  • Not following national breast cancer screening guidelines
  • High risk for breast cancer
  • Joint surgery within the last 6 months
  • Severe obesity (BMI over 35)
  • Migraine with aura
  • Poorly controlled diabetes
  • Use of female hormone supplements in the past 12 weeks
  • High risk of venous thromboembolism
  • Current cholecystitis, fibroids, or unexplained abnormal uterine bleeding
  • Current smoker
  • History of endometrial, ovarian, peritoneal, cervical, breast, or endocrine-dependent cancers
  • Receiving cancer treatment
  • Fragility bone fractures within 2 years
  • Other cognitive, musculoskeletal, neurological, or cardiorespiratory conditions affecting study participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive their assigned intervention for 12 weeks. Interventions include menopausal hormone therapy with daily application of 17 beta-Estradiol topical gel and micronized Progesterone tablets, muscle strengthening exercises demonstrated in 1 to 2 in-person therapy sessions with home exercises at least 3 times per week, or a combination of both. Participants in the usual care group continue their routine daily activities without additional intervention.

1 baseline visit and 1 follow-up visit at 12 weeks

Trial Site Locations

Total: 1 location

1

National University Hospital

Singapore, Singapore

Actively Recruiting

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Research Team

E

Eu-Leong Yong, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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