跳至主要内容
临床试验/NCT04255745
NCT04255745已完成不适用

The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2020年1月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Change in Blood Pressure

研究概览

简要总结

Current prevention and treatment of high blood pressure (BP) in sarcopenia, by non-pharmacological approaches remain limited and are far from optimal. This randomized control intervention pilot study will provide new evidence of the unexplored relationship between muscle strength and high BP in sarcopenia, and experimentally test the effects of an evidence-based progressive resistance training intervention on BP, while also examining reversibility to identify muscle strength as a non-pharmacological target for BP control in older sarcopenic adults.

详细描述

This premise of this K01 proposal is to address current gaps in the literature regarding the understanding of high blood pressure due to sarcopenia, and provide new evidence for the discernible relationship between low muscle strength and blood pressure in sarcopenia, and effective non-pharmaceutical treatment approaches. This study will evaluate the feasibility of recruitment, retention, implementation and adherence to an empirically-based progressive resistance training (PRT) intervention to test its effect on blood pressure in a targeted population of older adults with sarcopenia who are randomized (via block permuted scheme) to the PRT intervention. Built within this randomized control intervention design, the investigators will further explore reversibility to examine whether muscle strength serves as an intervention target for blood pressure control in sarcopenic adults, which will be more appropriately tested in subsequently well-powered R-level intervention studies. Physiologically plausible microvascular mechanisms by which the PRT impacts changes in blood pressure will also be explored.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Primary investigator will be masked to the outcome data collection

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

  • •Adults (men and women) aged 60 years and older (any racial/ethnic background)
  • •Demonstrates adequate cognitive function by the MoCA (education adjusted score of >22 at screening)
  • •Sedentary or low active adults (not active in strength training)
  • •Resides in the Chicagoland Area
  • •Able to walk/perform exercise without complete dependence on assisted device
  • •Able and willing to enroll and provide written informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to 1 of 2 treatment arms, follow through assignment during 3 months active period, participate in 1 follow-up visit at 12 months

排除标准

  • •Subjects with self-report of inability to walk at least ¼ mile or walk 400 meters in <15 minutes without sitting
  • •Subjects who self-reported having a history of a cardiovascular disease event or physician diagnosed cardiovascular disease (heart attack, heart failure, congenital heart disease, peripheral vascular disease, coronary revascularization, or angina that required overnight hospitalization), cerebrovascular disease (stroke, transient ischemic attack)
  • •Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 5 years;
  • •Subjects with orthopedic pathology or deformity that prevents exercising safely
  • •Diagnosis or history of cognitive impairment (Dementia, Alzheimer's Disease) or bipolar or psychotic disorder or hospitalization for psychological or emotional problems within the last 2 years
  • •Diagnosis of autoimmune diseases, such as (but not limited to) lupus, multiple sclerosis, advanced/severe rheumatoid arthritis that would preclude exercising safely
  • •Diagnosis of advanced or severe osteoporosis or orthopedic deformities that may prevent strength training exercise safely
  • •Participants from the same household as those already enrolled in the study
  • •Current abuser of alcohol or usage of illicit drugs or history of alcohol or drug abuse
  • •Planning to move out of the area or take an extended vacation during the study period
  • •Current or planned participation in in another structured program that overtly focuses on exercise
  • •Currently enrolled or planning to enroll into another research study that would limit full participation in the study
  • •Investigator discretion for clinical safety or protocol adherence reasons

研究组 & 干预措施

Assessment-only control

No Intervention

30 Assessment-only control group will be mailed (standard or electronic) NIH/National Institutes on Aging (NIA) Go4Life® educational materials once a month for 3 months. Exercise logs documenting weekly exercise activities, duration, time and effort will be requested to be sent back.

Intervention

Experimental

60 Intervention group will receive 12 weeks of supervised resistance training following the American Heart Association and American College of Sports Medicine guidelines for older adults. Exercises will include a mixture of upper-body and lower body strength exercises. Training load will be determined based on initial 1-repetition maximum tests (1-RM). Initial exercise load will start off at low resistance (40-50% 1RM) with more frequent repetitions per exercise, and will gradually increase weight load and intensity over the exercise training period.

干预措施: progressive resistance training (Behavioral)

结局指标

主要结局

Change in Blood Pressure

时间窗: baseline, 12 weeks

change in systolic and diastolic blood pressure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deepika Laddu-Patel

Associate Professor

Northwestern University

研究点 (1)

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