Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Auburn University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Number of sites successfully recruited
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Number of sites successfully recruited
Time Frame: 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
Time Frame: 24 weeks
75% session attendance
Likert scale assessment of protocol implementation
Time Frame: 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
Time Frame: 24 weeks
Participant Satisfaction Survey. Eight questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome.
Secondary Outcomes
- Grip strength(Change from 0-12 weeks, 12-24 weeks)
- Quality of Life T-score(Change from 0-12 weeks, 12-24 weeks)
- Subjective Frailty score (0-5)(Change from 0-12 weeks, 12-24 weeks)
- SWAY Memory Score(Change from 0-12 weeks, 12-24 weeks)
- Body composition(Change from 0-12 weeks, 12-24 weeks)
- Objective Frailty - Short Physical Performance Battery (SPPB)(Change from 0-12 weeks, 12-24 weeks)
- Physical activity - accelerometry(Change from 0-12 weeks, 12-24 weeks)
Investigators
Andrew Fruge
Assistant Professor
Auburn University