NCT05930470

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

April 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

April 19, 2023

Last Update Submit

July 3, 2023

Conditions

Frailty

Keywords

frailtyagingphysical performance

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Objective Frailty - Short Physical Performance Battery (SPPB)

    Change from 0-12 weeks, 12-24 weeks

  • Physical activity - accelerometry

    Change from 0-12 weeks, 12-24 weeks

  • Grip strength

    Change from 0-12 weeks, 12-24 weeks

  • Quality of Life T-score

    Change from 0-12 weeks, 12-24 weeks

  • Subjective Frailty score (0-5)

    Change from 0-12 weeks, 12-24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Delayed intervention

SHAM COMPARATOR

Sham treatment first, then Magnetic Mitohormesis Therapy treatment

Other: Magnetic Mitohormesis Therapy

Immediate intervention

EXPERIMENTAL

Magnetic Mitohormesis Therapy treatment first, then Sham treatment

Other: Magnetic Mitohormesis Therapy

Interventions

Magnetic Mitohormesis TherapyOTHER

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.

Also known as: Pulsed Electromagnetic Field Therapy
Delayed interventionImmediate intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 36934330BACKGROUND

  • 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.

    PMID: 36262374BACKGROUND

  • 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.

    PMID: 31518158BACKGROUND

  • 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.

    PMID: 32627872BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pao-Feng Tsai, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pao-Feng Tsai, PhD

CONTACT

334-844-5665tsaipaofeng@auburn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Sham-controlled crossover trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2023

First Posted

July 5, 2023

Study Start

April 26, 2023

Primary Completion

July 1, 2024

Study Completion

December 30, 2024

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)