Frailty
Conditions
Keywords
frailty, aging, physical performance
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.
Interventions
OTHERMagnetic 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.
Sponsors
QuantumTX Pte Ltd
Auburn University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Sham-controlled crossover trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence to intervention | 24 weeks | 75% session attendance |
| Number of sites successfully recruited | 1 year | 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 | 1 year | 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 | 24 weeks | Participant Satisfaction Survey. Eight questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Frailty score (0-5) | Change from 0-12 weeks, 12-24 weeks | Frail questionnaire, with higher scores indicating a better outcome |
| Objective Frailty - Short Physical Performance Battery (SPPB) | Change from 0-12 weeks, 12-24 weeks | Repeated Chair stand, balance test, and 4-meter walk composite score (0-12), with higher scores indicating a better outcome |
| Body composition | Change from 0-12 weeks, 12-24 weeks | Body Impedence Analyzer (InBody 720) lean body mass (in kilograms) |
| SWAY Memory Score | Change from 0-12 weeks, 12-24 weeks | SWAY Memory Test Score, ranging from 0-100, with higher scores indicating a better outcome |
| Physical activity - accelerometry | Change from 0-12 weeks, 12-24 weeks | Number of daily steps, with higher scores indicating a better outcome |
| Grip strength | Change from 0-12 weeks, 12-24 weeks | handheld dynamometry, with higher scores indicating a better outcome |
| Quality of Life T-score | Change from 0-12 weeks, 12-24 weeks | Research ANd Development (RAND) Short Form-12 will assess mental and physical quality of life, with higher scores indicating a better outcome |
Countries
United States
Contacts
Primary ContactPao-Feng Tsai, PhD
Outcome results
None listed