ArthralgiaPhase 2/3MUSENCT06530459
The MUSE Study for Menopausal Arthralgia
A Phase 2/3 study testing Menopausal hormone therapy, Exercise training and Menopausal hormone therapy + exercise training in people with Arthralgia and Menopause, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthralgia, Menopause, Perimenopausal Disorder
- What is being tested?
- Menopausal hormone therapy, Exercise training and Menopausal hormone therapy + exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Aug 2024to Apr 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia or psychiatric disorders, active liver disease or renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions.
- Pregnancy
- Non-adherence to national guidelines for breast cancer screening
- High risk for breast cancer
- Any joint surgery within the last 6 months
- Severe obesity: BMI>35
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- Migraine with aura
- Poorly controlled diabetes
- Use of any form of female hormone supplementation within the past 12 weeks.
- High venous thromboembolism risk
- Current cholecystitis, fibroids, or undiagnosed abnormal uterine bleeding.
- Current smoker.
- History of endometrial, ovarian, peritoneal, cervical, breast or endocrine-dependent cancers.
- Receiving treatment for any form of cancer.
- History of fragility bone fractures within the 2 years.
- Any other cognitive, musculoskeletal, neurological, and cardiorespiratory condition affecting one's ability to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Eu-Leong Yong
About this study
Official title: The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia
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.
Read the detailed description
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.
- Being tested
- Menopausal hormone therapy, Exercise training, Menopausal hormone therapy + exercise training
- Keywords
- Menopausal hormone therapy, Muscle strength, Exercise, Randomized controlled trial, Midlife women
- Medical subject headings
- Arthralgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menopausal hormone therapyDrug
Apply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily Ingest Micronized Progesterone 200mg daily for 12 days each month
Exercise trainingBehavioural
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. In all, there are up to 1-2 in-person therapy sessions and home sessions at least 3 times per week.
Menopausal hormone therapy + exercise trainingCombination product
- Apply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily and Ingest Micronized Progesterone 200mg daily for 12 days each month
- Exercises would focus on upper and lower body strength generally. It is anticipated that patients 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. In all, there are up to 1-2 in-person therapy sessions and home sessions at least 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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. Receives: Behavioral: Exercise training |
| Menopausal hormone therapy | Experimental | 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. Receives: Drug: Menopausal hormone therapy |
| Combination of exercise and menopausal hormone therapy | Experimental | 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. Receives: Combination Product: Menopausal hormone therapy + exercise training |
| Standard care | No intervention | Standard care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 12 weeks of intervention
Secondary outcomes (10)
Changes in Handgrip strength (kg)
Handgrip strength (kg) will be assessed twice on each arm, using the Jamar dynamometer.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: After 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Obstetrics & Gynaecology, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530459
- Sponsor's protocol ID
- 2023/00727
- Other IDs
- 2023
- Acronym
- MUSE
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MUScle Strengthening Exercises and Estrogen (MUSE) Randomized Controlled Trial for Menopausal Arthralgia
- ClinicalTrials.gov ID
- NCT06530459
- Acronym / sponsor ID
- MUSE / 2023/00727
- Keywords
- Menopausal hormone therapy, Muscle strength, Exercise, Randomized controlled trial, Midlife women
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise trainingCurated 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. |
| Menopausal hormone therapy | Experimental | Drug: Menopausal hormone therapyMenopausal hormone therapy comprising: 17beta-estradiol topical gel (1.25-2.5 gms) applied daily, and micronized Progesterone 200mg daily for 12 days each month. |
| Combination of exercise and menopausal hormone therapy | Experimental | Combination Product: Menopausal hormone therapy + exercise training1. 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. |
| Standard care | No intervention | –Standard care will be provided. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia or psychiatric disorders, active liver disease or renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions.
- Pregnancy
- Non-adherence to national guidelines for breast cancer screening
- High risk for breast cancer
- Any joint surgery within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menopausal hormone therapyApply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily Ingest Micronized Progesterone 200mg daily for 12 days each month | Drug | Menopausal hormone therapy |
| Exercise trainingExercises 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. In all, there are up to 1-2 in-person therapy sessions and home sessions at least 3 times per week. | Behavioural | Exercise |
| Menopausal hormone therapy + exercise training1. Apply 17 beta-Estradiol topical gel (1.25-2.5 gms) daily and Ingest Micronized Progesterone 200mg daily for 12 days each month 2. Exercises would focus on upper and lower body strength generally. It is anticipated that patients 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. In all, there are up to 1-2 in-person therapy sessions and home sessions at least 3 times per week. | Combination product | Combination of exercise and menopausal hormone therapy |
Primary outcome
Relative changes in perceived arthralgia at the end of intervention
Time frame: 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.
10 secondary outcomes
Changes in Handgrip strength (kg)
Time frame: After 12 weeks of intervention
Changes in isokinetic knee extension strength (degree/second)
Time frame: After 12 weeks of intervention
Changes in physical performance using the Physical Performance Battery
Time frame: After 12 weeks of intervention
Changes in associated menopausal symptoms using the Menopause Rating Scale (MRS)
Time frame: After 12 weeks of intervention
Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: After 12 weeks of intervention
Changes in anxiety symptoms using the GAD-7
Time frame: After 12 weeks of intervention
Changes in depression symptoms using the CES-D
Time frame: After 12 weeks of intervention
Changes in perceived quality of life using the SF-12.
Time frame: After 12 weeks of intervention
Changes in verbal memory measured using the Hopkins Verbal Learning Test
Time frame: After 12 weeks of intervention
Changes in insulin resistance using HOMA-IR
Time frame: After 12 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Menopausal hormone therapy, Exercise training and Menopausal hormone therapy + exercise training in people with Arthralgia and Menopause, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eu-Leong Yong, PhD (67724278, obgyel@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative changes in perceived arthralgia at the end of intervention (time frame: After 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.