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| Name | Class |
|---|---|
| QuantumTX Pte Ltd | NETWORK |
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Thirty (30) adults with limited physical function will be recruited to participate in a double-blind pilot randomized controlled crossover trial in which all participants will receive 12-weeks of twice weekly MMT treatment in the first (Phase 1) or second half (Phase 2) of the study period; during the control period, participants will receive sham treatment and will be blinded to the randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed intervention | Sham Comparator | Sham treatment first, then Magnetic Mitohormesis Therapy treatment |
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| Immediate intervention | Experimental | Magnetic Mitohormesis Therapy treatment first, then Sham treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Mitohormesis Therapy | Other | The MMT device that will be used in the trial will be the QuantumTx BIXEPS Fitness and Wellness. The apparatus will provide pulsed electromagnetic fields at flux densities 1.5 mT. During the treatment period, participants will receive PEMF therapy during two ten-minute sessions each week for a total of 12 weeks. The treatment period will be preceded or followed by 12 weeks of twice-weekly sham treatments depending on randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adherence to intervention | 75% session attendance | 24 weeks |
| Number of sites successfully recruited | Study recruitment, intervention, and data collection will be conducted at independent and assisted living facilities. Thus, reaching target accrual requires successful recruitment of these facilities. This outcome measures the actual number of study sites/facilities agreeing to and providing physical access and support to conduct the study. | 1 year |
| Likert scale assessment of protocol implementation | Study staff assessment of device usability and assessment protocol. Two questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome. | 1 year |
| Likert scale assessment of participant satisfaction | Participant Satisfaction Survey. Eight questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Frailty - Short Physical Performance Battery (SPPB) | Repeated Chair stand, balance test, and 4-meter walk composite score (0-12), with higher scores indicating a better outcome | Change from 0-12 weeks, 12-24 weeks |
| Physical activity - accelerometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pao-Feng Tsai, PhD | Contact | 334-844-5665 | tsaipaofeng@auburn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pao-Feng Tsai, PhD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Recruiting | Auburn | Alabama | 36849 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36934330 | Background | Venugobal S, Tai YK, Goh J, Teh S, Wong C, Goh I, Maier AB, Kennedy BK, Franco-Obregon A. Brief, weekly magnetic muscle therapy improves mobility and lean body mass in older adults: a Southeast Asia community case study. Aging (Albany NY). 2023 Mar 19;15(6):1768-1790. doi: 10.18632/aging.204597. Epub 2023 Mar 19. | |
| 36262374 | Background |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Sham-controlled crossover trial
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Number of daily steps, with higher scores indicating a better outcome |
| Change from 0-12 weeks, 12-24 weeks |
| Grip strength | handheld dynamometry, with higher scores indicating a better outcome | Change from 0-12 weeks, 12-24 weeks |
| Quality of Life T-score | Research ANd Development (RAND) Short Form-12 will assess mental and physical quality of life, with higher scores indicating a better outcome | Change from 0-12 weeks, 12-24 weeks |
| Subjective Frailty score (0-5) | Frail questionnaire, with higher scores indicating a better outcome | Change from 0-12 weeks, 12-24 weeks |
| SWAY Memory Score | SWAY Memory Test Score, ranging from 0-100, with higher scores indicating a better outcome | Change from 0-12 weeks, 12-24 weeks |
| Body composition | Body Impedence Analyzer (InBody 720) lean body mass (in kilograms) | Change from 0-12 weeks, 12-24 weeks |
| Stephenson MC, Krishna L, Pannir Selvan RM, Tai YK, Kit Wong CJ, Yin JN, Toh SJ, Torta F, Triebl A, Frohlich J, Beyer C, Li JZ, Tan SS, Wong CK, Chinnasamy D, Pakkiri LS, Lee Drum C, Wenk MR, Totman JJ, Franco-Obregon A. Magnetic field therapy enhances muscle mitochondrial bioenergetics and attenuates systemic ceramide levels following ACL reconstruction: Southeast Asian randomized-controlled pilot trial. J Orthop Translat. 2022 Oct 13;35:99-112. doi: 10.1016/j.jot.2022.09.011. eCollection 2022 Jul. |
| 31518158 | Background | Yap JLY, Tai YK, Frohlich J, Fong CHH, Yin JN, Foo ZL, Ramanan S, Beyer C, Toh SJ, Casarosa M, Bharathy N, Kala MP, Egli M, Taneja R, Lee CN, Franco-Obregon A. Ambient and supplemental magnetic fields promote myogenesis via a TRPC1-mitochondrial axis: evidence of a magnetic mitohormetic mechanism. FASEB J. 2019 Nov;33(11):12853-12872. doi: 10.1096/fj.201900057R. Epub 2019 Sep 13. |
| 32627872 | Background | Tai YK, Ng C, Purnamawati K, Yap JLY, Yin JN, Wong C, Patel BK, Soong PL, Pelczar P, Frohlich J, Beyer C, Fong CHH, Ramanan S, Casarosa M, Cerrato CP, Foo ZL, Pannir Selvan RM, Grishina E, Degirmenci U, Toh SJ, Richards PJ, Mirsaidi A, Wuertz-Kozak K, Chong SY, Ferguson SJ, Aguzzi A, Monici M, Sun L, Drum CL, Wang JW, Franco-Obregon A. Magnetic fields modulate metabolism and gut microbiome in correlation with Pgc-1alpha expression: Follow-up to an in vitro magnetic mitohormetic study. FASEB J. 2020 Aug;34(8):11143-11167. doi: 10.1096/fj.201903005RR. Epub 2020 Jul 6. |