Effect of Leg Strengthening Exercise After Hip Fracture

Official Title: “Effect of Leg Strengthening Exercise After Hip Fracture”

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.

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.

Intervention(s) in this Clinical Trial

• 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: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Exercise
  • High intensity lower extremity exercise
• Sham Comparator: Attention control
  • lower extremity TENS

Primary Measures

• lower extremity force production
  • Time Frame: one year after hip fracture
    Safety Issue?: No

Secondary Measures

• six minute walk distance
  • Time Frame: one year post fracture
    Safety Issue?: No
• free and fast gait speed
  • Time Frame: one year post fracture
    Safety Issue?: No
• modified physical performance test
  • Time Frame: one year post fracture
    Safety Issue?: No
• SF-36 physical function
  • Time Frame: one year post fracture
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Arcadia University Other

Overall Clinical Trial Officials and Contacts

Kathleen K Mangione, PT, PhD Principal Investigator Arcadia University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00997776

Study ID Number: MANGIONE-LEG STRENGTH 2006

ClinicalTrials.gov Identifier: NCT00997776

Health Authority: United States: Institutional Review Board