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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930470
• Other study ID #: AU MMT 23
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: Auburn University
• Contact: Pao-Feng Tsai, PhD
• Phone: 334-844-5665
• Email: tsaipaofeng[@]auburn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

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.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Auburn University	QuantumTX Pte Ltd

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adherence to intervention	75% session attendance	24 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	Physical activity - accelerometry	Number of daily steps, with higher scores indicating a better outcome	Change from 0-12 weeks, 12-24 weeks
Secondary	Grip strength	handheld dynamometry, with higher scores indicating a better outcome	Change from 0-12 weeks, 12-24 weeks
Secondary	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
Secondary	Subjective Frailty score (0-5)	Frail questionnaire, with higher scores indicating a better outcome	Change from 0-12 weeks, 12-24 weeks
Secondary	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
Secondary	Body composition	Body Impedence Analyzer (InBody 720) lean body mass (in kilograms)	Change from 0-12 weeks, 12-24 weeks