Improving Community Ambulation After Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 8
- 主要终点
- Ability to walk 300 meters or more in six minutes
研究概览
简要总结
Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults do not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program.
This study is being done to compare two 16-week supervised multi-part physical therapy programs (interventions) initiated up to 26 weeks after hip fracture. The investigators want to test whether the interventions lead to improvements in a person's ability to walk on their own in the home and in the local community. With this knowledge the investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health.
ANCILLARY STUDY #1 - MECHANISTIC PATHWAYS TO COMMUNITY AMBULATION (CAP-MP) The goal of this ancillary study is to investigate several mechanisms thought to be related to recovery in ambulatory ability after hip fracture. Selected mechanistic pathways are being investigated by obtaining mechanistic measurements of the participants randomized in the University of Maryland, Baltimore (UMB) clinical site of CAP.
ANCILLARY STUDY #2 - DIET AND DIETARY PATTERNS IN OLDER ADULTS UNDERGOING HIP FRACTURE REHABILITATION The goal of this ancillary study is to analyze dietary patterns for the nutritional characterization of older adults recovering from a hip fracture. The identified dietary patterns, as well as motivators and barriers to intake, will be assessed for their impact on the rate of return to community ambulation in participants randomized at the University of Connecticut Health Center (UCHC) clinical site of CAP.
ANCILLARY STUDY #3 - ROLE OF GLUCOSE METABOLISM IN STRENGTH AND FUNCTIONAL RECOVERY AFTER HIP FRACTURE The goal of this ancillary study is to assess the impact of glucose metabolism on strength and functional performance following resistance training in participants randomized at the UCHC clinical site of CAP.
ANCILLARY STUDY #4 - MUSCLE MECHANISMS UNDERLYING RECOVERY OF FUNCTION AFTER HIP FRACTURE The goal of this ancillary study is to understand some of the key muscle mechanisms associated with recovery in community ambulation following hip fracture in response to the two interventions for participants randomized at the Arcadia University (AU) clinical site of CAP.
详细描述
MAIN STUDY
Despite improvements in medical management, significant residual disability remains in older persons after a hip fracture. The goal of current clinical practice is independent, safe household ambulation two to three months after surgery. Hip fracture-acquired dependency in functional activities of daily living persists well beyond three months post-surgery. This residual disability indicates that current standard Medicare-reimbursed post-hip fracture rehabilitation (i.e., usual care) fails to return many patients to pre-fracture levels of function. In contrast to stroke and heart disease, other commonly occurring acute conditions in the older population, there are few intervention trials focused on decreasing disability following hip fracture. None of the trials for hip fracture has examined the effect of early post-fracture intervention on the ability to ambulate at a level required for independent function in the community (i.e., community ambulation). Thus, there is a paucity of evidence to justify extending medical management beyond usual care in persons following hip fracture to achieve community, rather than merely household, ambulation.
A randomized controlled trial (RCT) including 210 older adults who have experienced a hip fracture will be carried out at three clinical sites with half of the subjects receiving a specific multi-component intervention (PUSH) and the other half receiving a non-specific multi-component intervention (PULSE). Randomization of 210 participants meeting eligibility criteria will take place after post-acute rehabilitation ends, approximately 6 months (26 weeks) after admission to the hospital for hip fracture. The primary endpoint will be measured using the Six-Minute Walk Test (SMWT) at the end of the 16-week intervention period. The goal is to enable older adults who have experienced a hip fracture to recover sufficiently to become community ambulators.
Primary Aim The primary aim of the study is to determine if a specific multi-component 16-week intervention based on aerobic conditioning, specificity of training, and muscle overload (the PUSH intervention), initiated within 26 weeks of admission to the hospital for hip fracture, will be more successful in producing community ambulation at 16 weeks after randomization than a non-specific multi-component intervention of transcutaneous electrical nerve stimulation (TENS), flexibility activities, and active range of motion exercises (AROM) (the PULSE intervention).
Secondary Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Study PI (Magaziner) and Co-PI (Craik) and members of the Clinical Coordinating Center (Orwig, Lewis) are blinded to treatment assignment.
Clinical site PIs and clinical site coordinators who are responsible for assigning work and/or assessing for treatment fidelity of PTs in both groups are unblinded.
Staff who perform evaluations (clinical site visits and telephone interviews) after randomization and the Independent Safety Monitor (ISM) who will be blinded to treatment assignment.
The PTs only know specific information about the intervention he/she is delivering. To minimize "contamination" of the interventions, each PT provides only one of the interventions and PTs do not have contact with participants in the other group or with PTs providing the intervention to the other group. As PTs are hired for the study, they are assigned at random to one of the interventions.
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
- •Closed fracture of proximal femur
- •Age 60 or older at time of randomization
- •Minimal trauma fracture
- •Non-pathologic fracture
- •Surgical fixation of fracture
- •Living in the community at time of fracture
- •Ambulating without human assistance 2 months prior to fracture
- •Unable to walk 300 m or more in 6 minutes without human assistance at time of randomization
排除标准
- •Not English speaking
- •Does not live within reasonable distance of the clinical center
- •End stage renal disease on dialysis
- •Recent myocardial infarction
- •Uncompensated congestive heart failure
- •Lower extremity amputation
- •Symptoms of angina pectoris
- •Chest pain or shortness of breath (including from severe COPD)
- •Participant plans to move out of area or otherwise be unavailable during the 16-week intervention period
- •Participation in another clinical trial
- •Not community-residing (e.g., resident of a skilled nursing facility) at time of randomization
- •Not fully weight-bearing on fractured leg or non-fractured leg at time of randomization
- •Calculated creatinine clearance < 15 ml/min
- •Serum albumin < 2.5 g/dl
- •Hemoglobin < 9 g/dl
- •Receiving physical therapy for the hip fracture in the hospital or inpatient rehabilitation facility at time of randomization
- •Severely diminished lower extremity sensation or ulceration
- •Uncontrolled hypertension
- •Denied medical clearance by appropriate medical provider
- •Clinical site clinician thinks participant is not a good candidate for study (e.g., not likely to survive study period)
- •Cognitive impairment (3MS score <73)
- •Development of chest pain or substantial shortness of breath or ambulating with severe pain during baseline SMWT
- •Participant walks less than 4 meters in 40 seconds (<0.1 m/sec) during baseline SMWT
- •Not randomized by 26 weeks post admission for hip fracture
- •Final sign-off from study clinician and/or principal investigator is incomplete
- •Incomplete baseline data
- •Unable to contact participant
- •Participant is unable to provide her/his own informed consent
- •Participant refuses the study
结局指标
主要结局
Ability to walk 300 meters or more in six minutes
时间窗: 16 weeks post-randomization
The primary study outcome reflects the concept of a minimum distance a person needs to be able to walk to carry out usual activities in the community. This will be defined as achieving the threshold value of 300 meters or more on the Six-Minute Walk Test (SMWT). The SMWT is an assessment with excellent psychometric properties, and there is sound justification for a 300 m distance threshold on the SMWT (equivalent to walking at 0.8 m/s) to serve as an indicator for community ambulatory ability.
次要结局
- Endurance(16 weeks post-randomization and 40 weeks post-randomization for a subset of participants)
- Quadriceps muscle strength(16 weeks post-randomization and 40 weeks post-randomization for a subset of participants)
- Fast walking speed(16 weeks post-randomization and 40 weeks post-randomization for a subset of participants)
- Lower extremity function(16 weeks post-randomization and 40 weeks post-randomization for a subset of participants)
- Ability to walk 300 meters or more in six minutes(40 weeks post-randomization)
- Balance(16 weeks post-randomization and 40 weeks post-randomization for a subset of participants)
- Cost effectiveness: health care utilization(Every four weeks, up to 16 weeks post-randomization and up to 40 weeks post-randomization for a subset of participants)
- Short Physical Performance Battery (SPPB)(16 weeks post-randomization and 40 weeks post-randomization for a subset of participants)
研究者
Jay S. Magaziner
Professor and Chair
University of Maryland, Baltimore