Improving Community Ambulation After Hip Fracture

Completed · Not applicable

Conditions studied: Hip Fracture

In brief

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.

Key facts

Study ID

NCT01783704

Run by

University of Maryland, Baltimore

People needed

210

Starts

2013-06-10

Expected to finish

2017-10-17

Last updated by the study team

2022-01-27

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Dartmouth Medical School — Lebanon, New Hampshire, United States
• Arcadia University — Glenside, Pennsylvania, United States

Full record on ClinicalTrials.gov

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