跳至主要内容
临床试验/NCT02732366
NCT02732366已完成不适用

Living in Fitness Together (LIFT): Testing an Innovative Fall Prevention Program

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年5月1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
48
试验地点
1
主要终点
Intervention and Control Group Program Attendance

研究概览

简要总结

The purpose of this study is to test the feasibility and preliminary efficacy of a group-based fall prevention program for older adults.

详细描述

Falls are the leading cause of non-fatal and fatal injuries in older adults. The number of fall-related older adult deaths in 2005 reached 15,802. Overall, thirty percent of adults over the age of 65 fall every year, and the risk for falls increases dramatically with age. Direct medical costs related to falls reached $19 billion in 2000. In 2006 a national study found that 5.8 million older adults (16%) reported a fall in the prior 3 month period and 1.8 million had been injured. Falls and fall-related injuries have an important impact on mobility, functioning, and the quality of life of older adults, and for many, result in catastrophic mobility decline, loss of independence and institutionalization. The trends in falls and aging in the population make this a critical problem for our time.

Current evidence and guidelines recommend assessment of several important risk factors and providing individualized intervention for older adults at increased risk of falls. Strength, balance and gait training are among the most potent intervention elements. Evidence shows that fall risk benefits gained from exercise are completely lost within 12 weeks if exercise is not continued. Therefore, persistence with exercise and physical activity are critical to the long-term success of fall prevention treatments. The proposed project tests the feasibility and preliminary efficacy of an innovative group-based fall prevention program called Living In Fitness Together (LIFT). The program consists of group-based physical therapy for strength, balance, mobility and flexibility training, an individualized home program including walking for physical activity, and training of the group members to support and coach each other toward meeting their exercise and physical activity goals. It consists of 8 group sessions over 6 weeks plus one group booster session delivered by a physical therapist, occupational therapist and trained staff. The program is designed to deliver progressive, tailored, and challenging exercise intervention for older adults at risk for falls and empower older adults to meet their goals for exercise and physical activity through training in self-management, and peer-coaching within the exercise group. The aim of this project is to test the feasibility of implementing the fall prevention program with peer-coaching in the context of physical therapy practice, and to assess its safety and initial efficacy. The results of this study will be the foundation of a formal clinical trial of a novel program of exercise and peer- coaching for exercise adherence. This program has potential to be incorporated into physical therapy practice and disseminated widely, and to have an important impact on the number of falls and fall-related injuries that occur in older adults.

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 99 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adults aged 65 and over
  • •at risk for falls as identified by health care provider
  • •able to participate in group exercise with upper extremity support for balance (e.g. chair)

排除标准

  • •active vertigo, postural hypotension, unstable cardiac conditions
  • •major neurological disorders such as Parkinson's disease, recent major cerebrovascular event, multiple sclerosis, amyotrophic lateral sclerosis

研究组 & 干预措施

Group-based exercise and peer coaching

Experimental

This treatment arm will include physical therapist-led group-based exercise, goal-setting, peer coaching training, individualized home program, and activity monitoring.

干预措施: Group-based exercise and peer coaching (Behavioral)

Usual PT and attention control grp class

Active Comparator

This arm consists of the continuation of one-on-one PT along with participation in an attention control - healthy living class.

干预措施: Usual PT and attention control grp class (Other)

结局指标

主要结局

Intervention and Control Group Program Attendance

时间窗: 6 weeks

To assess feasibility of the intervention, the percentage of sessions attended by patients enrolled in the study will be collected.

Program Completion

时间窗: 6 weeks

To assess feasibility of the intervention, the number of patients who complete the program will be collected.

Adverse Events - Number of Events

时间窗: 6 months

Number of Adverse Events

Enrollment

时间窗: 6 months

To assess feasibility of the intervention, the number of patients identified as eligible, the number who refuse to participate, and the number who enroll in the study will be collected.

Adverse Events

时间窗: 6 months

To assess safety of the intervention, patients will be instructed to report all adverse events to the clinical investigators.

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

Christine McDonough

Assistant Professor of Physical Therapy

University of Pittsburgh

研究点 (1)

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