Effect of Leg Strengthening Exercise After Hip Fracture

Hip Fractures Clinical Trial

Official title:

Effect of Leg Strengthening Exercise After Hip Fracture

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

• Fractures, Bone
• Hip Fractures

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