The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relative changes in perceived arthralgia at the end of intervention
研究概览
简要总结
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.
详细描述
Recruited participants will be randomized to one of the following arms for 12 weeks: usual clinical care, 17b-Estradiol/progesterone (ET) only, Muscle strengthening exercises (MSE) only, combination of MSE plus ET. All participants will be assessed at Baseline and at 12 weeks.
Estrogen therapy (ET): Participants would apply 17b-estradiol (1.25-2.5 gms/daily) gel transdermally to joints and muscles most affected by arthralgia for 12 weeks. Participants with intact uteri would also be issued micronized Progesterone 200mg tablets to be taken orally for 12 days each month. Medications would be dispensed by the National University Hospital (NUH) pharmacy.
Muscle strengthening exercises (MSE) Exercises would be demonstrated in person by qualified staff physiotherapists. All Participants would be given a standard strength training protocol, with additional tailored exercises targeting their pain conditions, abilities and personal preferences. Exercises would focus on upper and lower body strength generally. Participants would be encouraged to exercise every day, alternating between upper and lower body strength training following the curated exercises. Exercise regimes would be reinforced through weekly reminders, and posts through social media.
MSE plus ET: Participants randomized to combination of would have both treatments administered at the same time within the same intervention period of 12 weeks. In other words, participants would be instructed to do the curated exercises and apply 17b-estradiol (1.25-2.5 gms/daily) gel trans-dermally with micronized progesterone oral tablets.
Usual care: Participants would continue their usual daily routines and come for outcome assessments at baseline and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Exercise training (Behavioral)
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.
干预措施: Menopausal hormone therapy (Drug)
Combination of exercise and menopausal hormone therapy
- 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.
干预措施: Menopausal hormone therapy + exercise training (Combination Product)
结局指标
主要结局
Relative changes in perceived arthralgia at the end of intervention
时间窗: After 12 weeks 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.
次要结局
- Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI)(After 12 weeks of intervention)
- Changes in physical performance using the Physical Performance Battery(After 12 weeks of intervention)
- Changes in depression symptoms using the CES-D(After 12 weeks of intervention)
- Changes in verbal memory measured using the Hopkins Verbal Learning Test(After 12 weeks of intervention)
- Changes in insulin resistance using HOMA-IR(After 12 weeks of intervention)
- Changes in Handgrip strength (kg)(After 12 weeks of intervention)
- Changes in isokinetic knee extension strength (degree/second)(After 12 weeks of intervention)
- Changes in anxiety symptoms using the GAD-7(After 12 weeks of intervention)
- Changes in associated menopausal symptoms using the Menopause Rating Scale (MRS)(After 12 weeks of intervention)
- Changes in perceived quality of life using the SF-12.(After 12 weeks of intervention)
研究者
Obstetrics & Gynaecology
Professor
National University Hospital, Singapore