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临床试验/NCT03990415
NCT03990415已完成不适用

Physical Function in Older Adults in the Stay Strong, Stay Healthy Program

Dana Duren2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Change in Balance During a Dynamic Task Using Force Plates.

研究概览

简要总结

The University of Missouri's Stay Strong, Stay Healthy (SSSH) program is an eight week strength training class for older adults. Exercise training programs, like SSSH, can increase muscle mass and strength, improve bone density and reduce the risk of osteoporosis and related fractures, improve diabetes, heart disease, arthritis, depression, and obesity; and increase self-confidence, sleep and vitality in older adults. Specifically, the SSSH program has been shown to increase elderly individuals' confidence in their physical abilities. The primary objective of this research study is to track physiologic changes and determine the effectiveness of the SSSH exercise intervention to improve balance and fall risk in older adults. Participant's balance, gait, muscle strength, body composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to and immediately following the eight week exercise intervention. After the intervention period participants will have the opportunity to participate in an interview process to further discuss their experiences and perceptions regarding the intervention and their health.

详细描述

Research Background and Objectives The University of Missouri's Stay Strong, Stay Healthy (SSSH) program is an eight week strength training class for older adults. SSSH is modeled after the evidence-based StrongWomen program developed by researchers at Friedman School of Nutrition Sciences at Tufts University. While the original Tufts program included only women, University of Missouri Extension has adapted the curriculum to also include men. Strength training programs, like SSSH, can increase muscle mass and strength, improve bone density and reduce the risk of osteoporosis and related fractures, improve diabetes, heart disease, arthritis, depression, and obesity; and increase self-confidence, sleep and vitality in older adults. Specifically, the SSSH program increases elderly individuals' confidence in their physical strength and balance. The present study will elucidate the effects of the SSSH program on specific measures of balance, muscle capacity, and skeletal health in a cohort of older adults from Central Missouri.

The primary objective of the quantitative part of the research study is to track physiologic changes and determine the effectiveness of the SSSH exercise intervention in older adults. Participant's balance, gait, muscle strength, body composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to and immediately following the eight week exercise intervention.

Participant centered objectives include:

  • Participants will improve their balance, thus reducing their risk for falls.
  • Participants will increase their muscle strength and improve body composition.
  • Participants will increase their rate of bone formation.
  • Participants will improve their cognition and sleep habits.
  • Participants will increase their physical activity

The primary objective of the qualitative part of the research study is to explore perceptions of the impact of physical activity and changes in behaviors and attitudes of participants who completed the intervention period. The sequential approach of this study will (1) explore the effects of participating in the Stay Strong, Stay Healthy study that were difficult to measure quantitatively and (2) help interpret the quantitative findings and understanding.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The primary investigator (Dr. Duren) will randomize participants into each of the three study groups. The research team responsible for assessments and analysis will be blinded to each participant's assignment. Dr. Duren will unblind the research team after the intervention period and data collection and analysis has been completed.

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are male or female ≥60 years of age
  • Are sedentary (no strength training and <30min/wk of other physical activity in the past 3 months)
  • Are ambulatory (cane or walker permitted)
  • Are free from current physical injury or illness preventing physical activity

排除标准

  • Answered YES to two or more questions on the PAR-Q form
  • Are female subjects who have not fully gone through menopause
  • Were a previous SSSH participant
  • Have dementia/Alzheimer's or other cognitive impairments that would limit ability to follow directions

结局指标

主要结局

Change in Balance During a Dynamic Task Using Force Plates.

时间窗: Baseline and at end of intervention period, typically 8 weeks.

Participants will complete the 30 second sit-to-stand dynamic balance task on two force plates, which will allow for a sensitive measure of balance. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline.

Change in Balance During a Static Task Using Force Plates.

时间窗: Baseline and at end of intervention period, typically 8 weeks.

Participants will complete the CDC 4 stance static balance task on force plates, allowing for a more sensitive measure of balance. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline.

次要结局

  • Changes in Grip Strength Using a Hand Dynamometer.(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in Walking Speed Using a 10 Meter Course.(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in the Timed Up and Go(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in Upper Body Muscle Flexibility Using the Back Scratch Test.(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in Lower Body Muscle Flexibility Using the Sit and Reach Test.(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in Bone Activity Using the Ratio of Serum Bone Turnover Markers (PINP ng/mL and CTX ng/mL).(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in Sleep Quality Using the Pittsburgh Sleep Quality Index Test.(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes in Cognition Performance Using the Self Administered Gerocognitive Examination.(Baseline and at end of intervention period, typically 8 weeks.)
  • Changes is Bone Mineral Density T-scores(Baseline and at end of intervention period, typically 8 weeks.)

研究者

发起方
Dana Duren
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dana Duren

Professor and Director of Orthopaedic Research at the Missouri Orthopaedic Institute

University of Missouri-Columbia

研究点 (2)

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