Pilot-testing the Effect of Magnetic Mitohormesis Therapy for Treating Frailty in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of sites successfully recruited
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of sites successfully recruited
时间窗: 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
时间窗: 24 weeks
75% session attendance
Likert scale assessment of protocol implementation
时间窗: 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
时间窗: 24 weeks
Participant Satisfaction Survey. Eight questions with likert scale responses ranging from 1-5, with a higher score meaning a better outcome.
次要结局
- 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)
研究者
Andrew Fruge
Assistant Professor
Auburn University