Clinical trial NCT05930470: Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults
Official title: Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Keywords: frailty
aging
physical performance
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: QuantumTX Pte Ltd
First posted: 2023-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Sham-controlled crossover trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* physical frailty or pre-frailty, indicated by Short Physical Performance Battery Score \<10;
* intact cognition indicated by a Mini-Cog Screening Test Score \> 2;
* able to read and write in English; and
* access to a telephone.

Exclusion Criteria:

* active malignancy;
* neuro-degenerative disease
* active electronic implants;
* any health conditions that would prevent performing the testing and intervention procedures;
* major surgical procedures within the last 6 months;
* major change in prescription medications within the last 3 months

Primary outcomes:
measure: Rate of adherence to intervention
timeFrame: 24 weeks
measure: Number of sites successfully recruited
timeFrame: 1 year
measure: Likert scale assessment of protocol implementation
timeFrame: 1 year
measure: Likert scale assessment of participant satisfaction
timeFrame: 24 weeks
Secondary outcomes:
measure: Objective Frailty - Short Physical Performance Battery (SPPB)
timeFrame: Change from 0-12 weeks, 12-24 weeks
measure: Physical activity - accelerometry
timeFrame: Change from 0-12 weeks, 12-24 weeks
measure: Grip strength
timeFrame: Change from 0-12 weeks, 12-24 weeks
measure: Quality of Life T-score
timeFrame: Change from 0-12 weeks, 12-24 weeks
measure: Subjective Frailty score (0-5)
timeFrame: Change from 0-12 weeks, 12-24 weeks
measure: SWAY Memory Score
timeFrame: Change from 0-12 weeks, 12-24 weeks
measure: Body composition
timeFrame: Change from 0-12 weeks, 12-24 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Pao-Feng Tsai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.