Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Delayed intervention Sham treatment first, then Magnetic Mitohormesis Therapy treatment |
Other: Magnetic Mitohormesis Therapy
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.
Other Names:
|
| Experimental: Immediate intervention Magnetic Mitohormesis Therapy treatment first, then Sham treatment |
Other: Magnetic Mitohormesis Therapy
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of adherence to intervention [24 weeks]
75% session attendance
- Number of sites successfully recruited [1 year]
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.
- Likert scale assessment of protocol implementation [1 year]
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.
- Likert scale assessment of participant satisfaction [24 weeks]
Participant Satisfaction Survey. Eight questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome.
Secondary Outcome Measures
- Objective Frailty - Short Physical Performance Battery (SPPB) [Change from 0-12 weeks, 12-24 weeks]
Repeated Chair stand, balance test, and 4-meter walk composite score (0-12), with higher scores indicating a better outcome
- Physical activity - accelerometry [Change from 0-12 weeks, 12-24 weeks]
Number of daily steps, with higher scores indicating a better outcome
- Grip strength [Change from 0-12 weeks, 12-24 weeks]
handheld dynamometry, with higher scores indicating a better outcome
- Quality of Life T-score [Change from 0-12 weeks, 12-24 weeks]
Research ANd Development (RAND) Short Form-12 will assess mental and physical quality of life, with higher scores indicating a better outcome
- Subjective Frailty score (0-5) [Change from 0-12 weeks, 12-24 weeks]
Frail questionnaire, with higher scores indicating a better outcome
- SWAY Memory Score [Change from 0-12 weeks, 12-24 weeks]
SWAY Memory Test Score, ranging from 0-100, with higher scores indicating a better outcome
- Body composition [Change from 0-12 weeks, 12-24 weeks]
Body Impedence Analyzer (InBody 720) lean body mass (in kilograms)
Eligibility Criteria
Criteria
Inclusion Criteria:
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physical frailty or pre-frailty, indicated by Short Physical Performance Battery Score <10;
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intact cognition indicated by a Mini-Cog Screening Test Score > 2;
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able to read and write in English; and
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access to a telephone.
Exclusion Criteria:
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active malignancy;
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neuro-degenerative disease
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active electronic implants;
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any health conditions that would prevent performing the testing and intervention procedures;
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major surgical procedures within the last 6 months;
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major change in prescription medications within the last 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Auburn University | Auburn | Alabama | United States | 36849 |
Sponsors and Collaborators
- Auburn University
- QuantumTX Pte Ltd
Investigators
- Principal Investigator: Pao-Feng Tsai, PhD, Auburn University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
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