Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530459
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-11
Brief Title:
The MUSE Study for Menopausal Arthralgia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The MUScle Strengthening Exercises and Estrogen MUSE Randomized Controlled Trial for Menopausal Arthralgia
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSE
Brief 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
Detailed Description:
Recruited participants will be randomized to one of the following arms for 12 weeks usual clinical care 17b-Estradiolprogesterone 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 125-25 gmsdaily 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 125-25 gmsdaily 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
Estrogen therapy ET Participants would apply 17b-estradiol 125-25 gmsdaily 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 125-25 gmsdaily 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None