Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty
• Intervention / Treatment: Other: Magnetic Mitohormesis Therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pao-Feng Tsai, PhD; Phone Number: 334-844-5665; Email: tsaipaofeng@auburn.edu

Study Locations

• United States
  • Alabama
    • Auburn, Alabama, United States, 36849
      • Recruiting
      • Auburn University
      • Contact: Andrew D Frugé, PhD; Phone Number: 334-844-8433; Email: fruge@auburn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Pulsed Electromagnetic Field Therapy
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: Pulsed Electromagnetic Field Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Auburn University
• Collaborators: QuantumTX Pte Ltd
• Investigators: Principal Investigator: Pao-Feng Tsai, PhD, Auburn University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: frailty; aging; physical performance
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: AU MMT 23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No