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

Study Overview
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Brief Summary
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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.

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

Conditions
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Frailty

Intervention / Treatment
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* Other: Magnetic Mitohormesis Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Sham-controlled crossover trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Delayed intervention<br>Sham treatment first, then Magnetic Mitohormesis Therapy treatment | Other: Magnetic Mitohormesis Therapy<br>* 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.<br>* Other names: Pulsed Electromagnetic Field Therapy;|
| Experimental: Immediate intervention<br>Magnetic Mitohormesis Therapy treatment first, then Sham treatment | Other: Magnetic Mitohormesis Therapy<br>* 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.<br>* Other names: Pulsed Electromagnetic Field Therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frailty, aging, physical performance