Back to resultsEffect of Leg Strengthening Exercise After Hip Fracture
Primary Purpose
Hip Fractures
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
progressive resistance exercise
TENS
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip Fracture, Exercise, Rehabilitation, Functional Performance
Eligibility Criteria
Inclusion Criteria:
- Successful fixation (partial or total hip replacement or open reduction internal fixation) of a hip fracture within the last 6 months
- Were 65 years of age or older, were living at home prior to the fracture, had a physician referral and were discharged from physical therapy.
Exclusion Criteria:
- Medical history of unstable angina or uncompensated congestive heart failure, ongoing chemotherapy or renal dialysis, history of stroke with residual hemiplegia, Parkinson disease, absent sensation in the lower extremities due to sensory neuropathy, life expectancy of less than 6 months, and Folstein mental status scores < 20.
Sites / Locations
- Arcadia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Exercise
Attention control
Arm Description
High intensity lower extremity exercise
lower extremity TENS
Outcomes
Primary Outcome Measures
lower extremity force production
Secondary Outcome Measures
six minute walk distance
free and fast gait speed
modified physical performance test
SF-36 physical function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00997776
Brief Title
Effect of Leg Strengthening Exercise After Hip Fracture
Official Title
Effect of Leg Strengthening Exercise After Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arcadia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial was to examine the effectiveness of a short-term leg strengthening exercise program compared to attention control on improving leg strength, walking speed and endurance, physical performance, and physical function one year after hip fracture.
Detailed Description
Poor functional outcomes are reported for the majority of older adults who sustain a hip fracture. The ability of hip fracture patients to make sustained functional improvements above and beyond natural recovery is unknown. It has been shown that gym-based programs can help old adults regain function after hip fracture. It is unclear if these results could be translated into the home setting that lacks the gym-based equipment, or if improvement would be sustainable. This program compares high intensity strength training performed in the home twice weekly for 10 weeks to an attention placebo control in which participants receive sensory electrical stimulation to leg muscles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip Fracture, Exercise, Rehabilitation, Functional Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
High intensity lower extremity exercise
Arm Title
Attention control
Arm Type
Sham Comparator
Arm Description
lower extremity TENS
Intervention Type
Other
Intervention Name(s)
progressive resistance exercise
Other Intervention Name(s)
strengthening exercise
Intervention Description
lower extremity strengthening: 3 sets of 8 repetitions at the 8 repetition maximum (8RM)for the hip and knee extensors, hip abductors, plantarflexors twice weekly for 10 weeks.
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
Transcutaneous electrical nerve stimulation (TENS) to elicit sensory information (comfortable tingling) for 7 minutes to bilateral muscle groups including the gluteal muscles, quadriceps, and gastroc-soleus muscles. TENS administered twice weekly for 10 weeks.
Primary Outcome Measure Information:
Title
lower extremity force production
Time Frame
one year after hip fracture
Secondary Outcome Measure Information:
Title
six minute walk distance
Time Frame
one year post fracture
Title
free and fast gait speed
Time Frame
one year post fracture
Title
modified physical performance test
Time Frame
one year post fracture
Title
SF-36 physical function
Time Frame
one year post fracture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful fixation (partial or total hip replacement or open reduction internal fixation) of a hip fracture within the last 6 months
Were 65 years of age or older, were living at home prior to the fracture, had a physician referral and were discharged from physical therapy.
Exclusion Criteria:
Medical history of unstable angina or uncompensated congestive heart failure, ongoing chemotherapy or renal dialysis, history of stroke with residual hemiplegia, Parkinson disease, absent sensation in the lower extremities due to sensory neuropathy, life expectancy of less than 6 months, and Folstein mental status scores < 20.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen K Mangione, PT, PhD
Organizational Affiliation
Arcadia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arcadia University
City
Glenside
State/Province
Pennsylvania
ZIP/Postal Code
19038
Country
United States
12. IPD Sharing Statement
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Effect of Leg Strengthening Exercise After Hip Fracture
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