Effect of Leg Strengthening Exercise After Hip Fracture

NCT ID: NCT00997776

Last Updated: 2009-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2006-06-30

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise

High intensity lower extremity exercise

Group Type: EXPERIMENTAL

progressive resistance exercise

Intervention Type: OTHER

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.

Attention control

lower extremity TENS

Group Type: SHAM_COMPARATOR

TENS

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

strengthening exercise

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcadia University

OTHER

Sponsor Role: lead

Responsible Party

Arcadia University

Principal Investigators

Kathleen K Mangione, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Arcadia University

Locations

Arcadia University

Glenside, Pennsylvania, United States

Countries

United States

Other Identifiers

1R03HD041944-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MANGIONE-LEG STRENGTH 2006

Identifier Type: -

Identifier Source: org_study_id