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FrailtyNCT05930470

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

A study testing Magnetic Mitohormesis Therapy in people with Frailty, run by Auburn University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Frailty
What is being tested?
Magnetic Mitohormesis Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
26 Apr 2023to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pao-Feng Tsai, PhD contact

334-844-5665

tsaipaofeng@auburn.edu

United States1 site, 1 recruiting

  • Auburn University

    Auburn, Alabama, 36849

    Andrew D Frugé, PhD, 334-844-8433, fruge@auburn.edu

    Recruiting

Other trials in United States

About this study

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.

Conditions
Frailty
Being tested
Magnetic Mitohormesis Therapy
Keywords
frailty, aging, physical performance
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Mitohormesis TherapyOther

    Also called Pulsed Electromagnetic Field 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.

Study groups in NCT05930470
Study groupRoleWhat they receive
Delayed interventionSham comparatorSham treatment first, then Magnetic Mitohormesis Therapy treatment
Receives: Other: Magnetic Mitohormesis Therapy
Immediate interventionExperimentalMagnetic Mitohormesis Therapy treatment first, then Sham treatment
Receives: Other: Magnetic Mitohormesis Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of adherence to intervention

    75% session attendance

    Measured: 24 weeks

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 24 weeks

Secondary outcomes (7)

  1. 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

    Measured: Change from 0-12 weeks, 12-24 weeks

  2. Physical activity - accelerometry

    Number of daily steps, with higher scores indicating a better outcome

    Measured: Change from 0-12 weeks, 12-24 weeks

  3. Grip strength

    handheld dynamometry, with higher scores indicating a better outcome

    Measured: Change from 0-12 weeks, 12-24 weeks

  4. 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

    Measured: Change from 0-12 weeks, 12-24 weeks

  5. Subjective Frailty score (0-5)

    Frail questionnaire, with higher scores indicating a better outcome

    Measured: Change from 0-12 weeks, 12-24 weeks

  6. SWAY Memory Score

    SWAY Memory Test Score, ranging from 0-100, with higher scores indicating a better outcome

    Measured: Change from 0-12 weeks, 12-24 weeks

  7. Body composition

    Body Impedence Analyzer (InBody 720) lean body mass (in kilograms)

    Measured: Change from 0-12 weeks, 12-24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2023
  2. Study start26 Apr 2023
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Sham-controlled crossover trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05930470
Sponsor's protocol ID
AU MMT 23
Status last verified
Jul 2023
First submitted
19 Apr 2023
Last updated
5 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36934330

  • 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.

    PubMed 36262374

  • 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.

    PubMed 31518158

  • 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.

    PubMed 32627872

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Mitohormesis Therapy in people with Frailty, run by Auburn University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pao-Feng Tsai, PhD (334-844-5665, tsaipaofeng@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of adherence to intervention (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05930470, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.

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