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

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Mitohormesis Therapy
Sponsored by
Auburn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring frailty, aging, physical performance

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Auburn UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Delayed intervention

Immediate intervention

Arm Description

Sham treatment first, then Magnetic Mitohormesis Therapy treatment

Magnetic Mitohormesis Therapy treatment first, then Sham treatment

Outcomes

Primary Outcome Measures

Rate of adherence to intervention
75% session attendance
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.
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.
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.

Secondary Outcome Measures

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
Physical activity - accelerometry
Number of daily steps, with higher scores indicating a better outcome
Grip strength
handheld dynamometry, with higher scores indicating a better outcome
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
Subjective Frailty score (0-5)
Frail questionnaire, with higher scores indicating a better outcome
SWAY Memory Score
SWAY Memory Test Score, ranging from 0-100, with higher scores indicating a better outcome
Body composition
Body Impedence Analyzer (InBody 720) lean body mass (in kilograms)

Full Information

First Posted
April 19, 2023
Last Updated
July 3, 2023
Sponsor
Auburn University
Collaborators
QuantumTX Pte Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05930470
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
QuantumTX Pte Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
frailty, aging, physical performance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Sham-controlled crossover trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Delayed intervention
Arm Type
Sham Comparator
Arm Description
Sham treatment first, then Magnetic Mitohormesis Therapy treatment
Arm Title
Immediate intervention
Arm Type
Experimental
Arm Description
Magnetic Mitohormesis Therapy treatment first, then Sham treatment
Intervention Type
Other
Intervention Name(s)
Magnetic Mitohormesis Therapy
Other Intervention Name(s)
Pulsed Electromagnetic Field Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of adherence to intervention
Description
75% session attendance
Time Frame
24 weeks
Title
Number of sites successfully recruited
Description
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.
Time Frame
1 year
Title
Likert scale assessment of protocol implementation
Description
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.
Time Frame
1 year
Title
Likert scale assessment of participant satisfaction
Description
Participant Satisfaction Survey. Eight questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Objective Frailty - Short Physical Performance Battery (SPPB)
Description
Repeated Chair stand, balance test, and 4-meter walk composite score (0-12), with higher scores indicating a better outcome
Time Frame
Change from 0-12 weeks, 12-24 weeks
Title
Physical activity - accelerometry
Description
Number of daily steps, with higher scores indicating a better outcome
Time Frame
Change from 0-12 weeks, 12-24 weeks
Title
Grip strength
Description
handheld dynamometry, with higher scores indicating a better outcome
Time Frame
Change from 0-12 weeks, 12-24 weeks
Title
Quality of Life T-score
Description
Research ANd Development (RAND) Short Form-12 will assess mental and physical quality of life, with higher scores indicating a better outcome
Time Frame
Change from 0-12 weeks, 12-24 weeks
Title
Subjective Frailty score (0-5)
Description
Frail questionnaire, with higher scores indicating a better outcome
Time Frame
Change from 0-12 weeks, 12-24 weeks
Title
SWAY Memory Score
Description
SWAY Memory Test Score, ranging from 0-100, with higher scores indicating a better outcome
Time Frame
Change from 0-12 weeks, 12-24 weeks
Title
Body composition
Description
Body Impedence Analyzer (InBody 720) lean body mass (in kilograms)
Time Frame
Change from 0-12 weeks, 12-24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pao-Feng Tsai, PhD
Phone
334-844-5665
Email
tsaipaofeng@auburn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pao-Feng Tsai, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew D Frugé, PhD
Phone
334-844-8433
Email
fruge@auburn.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36934330
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.
Results Reference
background
PubMed Identifier
36262374
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.
Results Reference
background
PubMed Identifier
31518158
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.
Results Reference
background
PubMed Identifier
32627872
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.
Results Reference
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Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults

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