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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00997776
Other study ID # MANGIONE-LEG STRENGTH 2006
Secondary ID 1R03HD041944-01A
Status Completed
Phase Phase 1/Phase 2
First received October 18, 2009
Last updated October 18, 2009
Start date August 2002
Est. completion date June 2006

Study information

Verified date October 2009
Source Arcadia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date June 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Arcadia University Glenside Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Arcadia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary lower extremity force production one year after hip fracture No
Secondary six minute walk distance one year post fracture No
Secondary free and fast gait speed one year post fracture No
Secondary modified physical performance test one year post fracture No
Secondary SF-36 physical function one year post fracture No
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