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Effect of Leg Strengthening Exercise After Hip Fracture

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ClinicalTrials.gov Identifier: NCT00997776
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Arcadia University

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Other: progressive resistance exercise Other: TENS Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Leg Strengthening Exercise After Hip Fracture
Study Start Date : August 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercise
High intensity lower extremity exercise
Other: progressive resistance exercise
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.
Other Name: strengthening exercise
Sham Comparator: Attention control
lower extremity TENS
Other: TENS
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 Measures :
  1. lower extremity force production [ Time Frame: one year after hip fracture ]

Secondary Outcome Measures :
  1. six minute walk distance [ Time Frame: one year post fracture ]
  2. free and fast gait speed [ Time Frame: one year post fracture ]
  3. modified physical performance test [ Time Frame: one year post fracture ]
  4. SF-36 physical function [ Time Frame: one year post fracture ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997776


Locations
United States, Pennsylvania
Arcadia University
Glenside, Pennsylvania, United States, 19038
Sponsors and Collaborators
Arcadia University
Investigators
Principal Investigator: Kathleen K Mangione, PT, PhD Arcadia University

Responsible Party: Kathleen Kline Mangione, Professor, Arcadia University
ClinicalTrials.gov Identifier: NCT00997776     History of Changes
Other Study ID Numbers: MANGIONE-LEG STRENGTH 2006
1R03HD041944-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009

Keywords provided by Arcadia University:
Hip Fracture
Exercise
Rehabilitation
Functional Performance

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries