Role of Exercise in Reversal of Hospitalization-associated Disability in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Activities of Daily Living
研究概览
简要总结
The proposed preliminary study from this interdisciplinary team will provide important information about the feasibility and safety of bedside low intensity pedaling exercise during hospitalization. The findings from this study are essential to develop high-value, effective treatments that can be used by any hospital setting throughout the country. The program that investigators are proposing may provide important changes in how disability can be prevented in elderly patients who are hospitalized because of an acute illness.
详细描述
The study design includes 2 phases (10 months each) for development and evaluation of the testing and intervention protocol. The last 4 months of the study will be devoted to preparation of a larger randomized controlled clinical trial grant submission. Mixed methods will be used in both phases.
Phase I will focus on developing, testing and refining the measurement protocol and bedside tailored low intensity pedaling exercise (Ex) program using mixed methods. During this 10-month phase, researchers plan to enroll 10 participants who are admitted to a medical surgical (MS) unit and meet study eligibility criteria. Investigators will implement our proposed testing and intervention protocol,obtain feedback and make modifications as necessary. For this purpose the study team will use a process improvement framework with rapid cycle improvements. The outcome for Phase I will be development of a manual of operations for the testing and Ex protocol that will be implemented in Phase II.
Phase II (10 months) will randomly assign 60 patients over the age of 65 years who meet medical criteria and are admitted to a medical surgical (MS) hospital unit at the VA Palo Alto Health care system (VAPA HCS) to one of two groups, 1) low intensity bedside pedaling exercise or 2) usual care. All participants will be asked to complete questionnaires, undergo a Short Physical Performance Battery (SPPB), cognitive testing and a blood draw prior to participation in the Ex program (baseline). All testing and blood draw will be repeated within 24 hours prior to discharge (release from the hospital to home or other facility, indicating that their condition has been resolved or adequately treated or is stabilized during their hospital stay) from the hospital(approximately at 5-6 days). Participants will be followed for the duration of the hospital stay, an expected average length of 5-6 days. Additionally, all participants will be asked to continue to exercise after discharge to home for 4 weeks. All tests will be performed at baseline (prior to intervention), within 24 hours prior to discharge (release from the hospital to home or other facility, indicating that their condition has been resolved or adequately treated or is stabilized during their hospital stay)from the hospital, on average 5-6 days) and again at 4 weeks post discharge. The focus of Phase II is safety and feasibility of the intervention and association with outcome measures. The length of stay (LOS) at VAPA HCS is approximately 6 days. Thus, the study investigators anticipate that each individual will be enrolled approximately 5 days and participate in an average of 8 training sessions. Investigators will also examine the association between physical activity levels at baseline (pre Ex) and myokines and associated changes in myokines after intervention.
A description of the Ex program:
Individually tailored, low intensity bedside pedaling exercise:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •age 65 years or older
- •Able to tolerate exercise
- •Non-elective admission to hospital
排除标准
- •Elective admission with expected LOS of 2 days or less
- •Diagnosed with Dementia or Alzheimer's disease
- •Lower extremity amputation
- •Severe arthritis limiting ability to perform pedaling exercise
- •Uncontrolled hypertension
- •Hypotension
- •Non-English speaking
- •Participating in another clinical trial
结局指标
主要结局
Activities of Daily Living
时间窗: Change from Baseline (Admission) to Discharge (approximately 3-5 days in length)
Discharge is considered release from the hospital to home or other facility, indicating that their condition has been resolved or adequately treated or is stabilized during their hospital stay. On average we anticipate the time frame between hospital admission and discharge to be variable but between 3-5 days in length.
次要结局
- Short Physical Performance Battery(Change from Baseline (Admission) to Discharge (approximately 3-5 days in length))
- Instrumental Activities of Daily Living(Change from Baseline (Admission) to Discharge (approximately 3-5 days in length))
研究者
Roberta Oka
Associate Chief Nurse for Research and Advanced Practice Nursing
Palo Alto Veterans Institute for Research
