Hip FracturesPhase 1/2NCT00997776
Effect of Leg Strengthening Exercise After Hip Fracture
A Phase 1/2 study testing progressive resistance exercise and TENS in people with Hip Fractures, run by Arcadia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- progressive resistance exercise and TENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jun 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- progressive resistance exercise, TENS
- Keywords
- Hip Fracture, Exercise, Rehabilitation, Functional Performance
- Medical subject headings
- Hip Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive resistance exerciseOther
Also called strengthening 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.
TENSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | High intensity lower extremity exercise Receives: Other: progressive resistance exercise |
| Attention control | Sham comparator | lower extremity TENS Receives: Other: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower extremity force production
Measured: one year after hip fracture
Secondary outcomes (4)
six minute walk distance
Measured: one year post fracture
free and fast gait speed
Measured: one year post fracture
modified physical performance test
Measured: one year post fracture
SF-36 physical function
Measured: one year post fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startAug 2002
- Primary completionJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcadia University
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen K Mangione, PT, PhD, Principal investigator, Arcadia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997776
- Sponsor's protocol ID
- MANGIONE-LEG STRENGTH 2006
- Other IDs
- 1R03HD041944-01A1
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Leg Strengthening Exercise After Hip Fracture
- ClinicalTrials.gov ID
- NCT00997776
- Acronym / sponsor ID
- MANGIONE-LEG STRENGTH 2006
- Conditions
- Hip Fractures
- Keywords
- Hip Fracture, Exercise, Rehabilitation, Functional Performance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Arcadia UniversityUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: progressive resistance exerciseHigh intensity lower extremity exercise |
| Attention control | Sham comparator | Other: TENSlower extremity TENS |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive resistance exerciseAlso: strengthening exerciselower 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 | Exercise |
| TENSTranscutaneous 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. | Other | Attention control |
Primary outcome
lower extremity force production
Time frame: one year after hip fracture
4 secondary outcomes
six minute walk distance
Time frame: one year post fracture
free and fast gait speed
Time frame: one year post fracture
modified physical performance test
Time frame: one year post fracture
SF-36 physical function
Time frame: one year post fracture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen K Mangione, PT, PhD principal investigator
Arcadia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing progressive resistance exercise and TENS in people with Hip Fractures, run by Arcadia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower extremity force production (time frame: one year after hip fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2009.