Comparison of Two Exercise Interventions to Improve Gait in Older Persons: The PRIME (Program to Improve Mobility in The Elderly) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Physical function
研究概览
简要总结
The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. The investigators want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength.
详细描述
The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. We want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength.
Adults aged 65 years or older, who are able to walk without the help of another person, are being asked to participate. If you are able to walk independently and you have medical clearance from your physician to participate in activities requiring low to moderate physical activity, you are invited to participate. We plan to enroll 40 older adults, all who have small problems with walking due to balance or strength, in this research study.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age and older
- •Ambulatory without an assistive device or the assistance of another person
- •Usual 4 meter gait speed ≥1.0 m/s
- •Completes a figure-of-eight walk in > 8.0 seconds
排除标准
- •Inability to participate in testing:
- •persistent lower extremity pain that is present on most days of the week and crepitus, tenderness or enlargement of joints of the lower extremity (arthritis).84
- •back pain that is present on most days of the weeks and interferes with walking and activities of daily living or back pain that increases with walking (lumbar stenosis)
- •calf pain or cramping which worsens with walking and is relieved by rest (PAD)
- •refusal to walk on a treadmill
- •Safety concerns:
- •dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
- •any acute illness or medical condition that is not stable according to the approving physician
- •resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute85
- •diagnosed dementia or cognitive impairment defined as a MMSE score < 24
- •hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
- •severe visual impairment with visual acuity < 20/70 with best correction
- •history of stroke
- •fixed or fused lower extremity joints such as hip, knee or ankle
- •lower extremity strength <4/5 on manual muscle testing
- •lower extremity amputation
- •progressive movement disorder such as MS, ALS or Parkinson's disease
研究组 & 干预措施
skill-based exercise
2 times per week for 12 weeks. warm-up, stretching, strengthening, and skill-based exercises. Pre-gait and gait activities including stepping patterns and walking patterns and treadmill training at various walking speeds
干预措施: skill based exercise (Behavioral)
aerobic exercise training
warm-up, strengthening and aerobic conditioning (treadmill walking)
干预措施: aerobic conditioning (Behavioral)
结局指标
主要结局
Physical function
时间窗: 12 weeks
LLFDI function and disability scales
Physical Activity
时间窗: 12 weeks
Actigraph accelerometer
Gait
时间窗: 12 weeks
gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8
次要结局
- Disability and health care costs(6 months post exercise)
研究者
Jennifer S. Brach
Associate Professor
University of Pittsburgh