Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults
- Conditions
- Frailty
- Interventions
- Other: Magnetic Mitohormesis Therapy
- Registration Number
- NCT05930470
- Lead Sponsor
- Auburn University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Delayed intervention Magnetic Mitohormesis Therapy Sham treatment first, then Magnetic Mitohormesis Therapy treatment Immediate intervention Magnetic Mitohormesis Therapy Magnetic Mitohormesis Therapy treatment first, then Sham treatment
- Primary Outcome Measures
Name Time Method 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.
Rate of adherence to intervention 24 weeks 75% session attendance
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 Outcome Measures
Name Time Method 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
Subjective Frailty score (0-5) Change from 0-12 weeks, 12-24 weeks Frail questionnaire, with higher scores indicating a better outcome
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
Body composition Change from 0-12 weeks, 12-24 weeks Body Impedence Analyzer (InBody 720) lean body mass (in kilograms)
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
Physical activity - accelerometry Change from 0-12 weeks, 12-24 weeks Number of daily steps, with higher scores indicating a better outcome
Trial Locations
- Locations (1)
Auburn University
🇺🇸Auburn, Alabama, United States