Osteoarthritis, KneeNCT01545986
A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty
A study testing Exercise in people with Osteoarthritis, Knee, run by Helen Hayes Hospital at 1 site in United States.
Trial summary
The purpose of this study was to compare the effects of two exercise programs, using low velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have undergone total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2011
- Phase
- Interventional
- 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 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 60- 89 years of age.
- primary unilateral TKA 10-21 days prior to the outpatient PT evaluation
- received inpatient rehabilitation at Helen Hayes Hospital
Who cannot join
- Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing
- any other lower extremity joint replacement surgery
- diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes
- chest pain or shortness of breath on stair-climbing
- requirement of human assistance to walk in addition to the ambulation device
- inability to follow instructions to perform testing and/or exercise,
- participants who stated that they would not be available to complete 12 exercise sessions
- individual adherence with performance of a home exercise program (HEP) less than five of seven days at the end of the treatment period
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Hayes Hospital
West Haverstraw, New York, 10993
About this study
Official title: A Comparative Analysis of High Velocity and Standard Low Velocity Exercise Training on Rehabilitation Outcomes Following Total Knee Arthroplasty
The purpose of this study was to compare the effects of two exercise programs, using low velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals performing HV exercise, compared to LV, would exhibit superior outcomes.
Read the detailed description
The most effective type of exercise has not been identified for individuals who undergo total knee arthroplasty (TKA). High velocity (HV) exercise when compared to low velocity (LV) exercise produces greater gains in power and certain functional activities in older adults. The use of HV exercise for patients who undergo TKA has not been investigated.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Exercise
- Keywords
- Joint Replacement, Exercise, Power training
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Rehabilitation
Participants attended standardized exercise (ex) sessions twice a week for six weeks for 12 sessions. Group speed differed for concentric contractions, sit to stand ex, walking, curbs, and stairs. The low velocity ex group performed a concentric contraction in two seconds, and high velocity group in one second or less. End range concentric hold, eccentric contraction, repetition (rep) rest and set rest were the same. Open chain ex was performed at 50% of one Repetition Maximum (RM) x 10 reps x one set and then 80% of 1RM x 10 reps x two sets. Curb height and 1RM was assessed at the first, fifth and ninth sessions. Manual stretching, balance ex, sit to stand support, level of aerobic ex, gait training, and functional training were assessed and progressed at any session.
| Study group | Role | What they receive |
|---|---|---|
| High Velocity Exercise | Experimental | The high velocity exercise group performed the concentric contraction phase of resisted exercise in one second or less. This group performed sit to stand exercise, walking, curbs, and stairs as fast as was comfortable without an increased limp. Other exercises were performed at the participant preferred rate. Receives: Behavioral: Exercise |
| Low Velocity exercise | Active comparator | The low velocity exercise group performed the concentric contraction phase of resisted exercise in two seconds. This group performed sit to stand exercise, walking, curbs, stairs, and other exercises at the participant preferred rate. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Six Minute Walk Test (6MWT) at six weeks
The distance walked in six minutes is measured for the 6MWT. A 150 foot hallway is used for the test. Standardized instructions are read to the participant. The participant is asked to walk as fast as he/she feels comfortable and safe in order to walk far as he/she can during six minutes. Distance is recorded in feet and later is converted to meters.
Measured: 6 weeks
Secondary outcomes (6)
Gait Abnormality Rating Scale (GARS)
The GARS is a rating of gait quality. The participant is videotaped walking 10 meters from front, back, left, and right views. No type of walking aid is allowed. Standardized instructions are read to the participant including that he/she should walk at his/her usual speed. At a later time the videotape is viewed to rate gait on a four point (0-3) Likert type scale. Zero is gait without deviations and 48 is greatest amount of gait deviations.
Measured: 6 weeks
Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks
The VAS Pain is a 10 cm horizontal line with the words "severe moderate slight" spread out along the whole length. The end points are labeled "Pain as bad as it could be" and "No pain". A pencil is given to the participant to mark his/her answer. Standardized instructions are read to the participant. The test is scored by a number from 0 to 100 as measured in mm along the line with zero being no pain and 100 being pain as bad as it could get.
Measured: 6 weeks
Change from Baseline in Timed Up and Go Test (TUG) at six weeks
The TUG records the time in seconds needed to stand from sitting, walk 3 meters, return, and sit into the chair. A standard chair with armrests is used. Assistive devices are allowed but no physical assistance is given. Standardized instructions are read to the participant. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.
Measured: 6 weeks
Gait Velocity
The participant walks while being videotaped. Standardized instructions are read to the participant when he/she is told that he/she should walk at his/her usual pace to the end of a 10 meter walkway. A side view is used. The videotape is viewed later for scoring. The acceleration and deceleration time is excluded by recording only the time taken to walk across the central 4 meters. This time and the 4 meter distance are used to calculate velocity in meters per second.
Measured: 6 weeks
Change from Baseline in Short Form-36 (SF-36) at six weeks
The Short Form-36 (SF-36) is a 36 item paper questionnaire which measures general health. Standarized instructions read to the participant prior to him/her filling it out. Scores range from 0-100, with 100 being highest level of physical and mental health.
Measured: 6 weeks
Change from Baseline in Stair Climb Test at six weeks
The time used to climb a flight of 12 steps and descend is recorded. Standardized instructions are read to the participant. Time is recorded in seconds. A practice walk through is given. Due to the possibility of fatigue the faster of the two times is recorded.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Hayes Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie A. Kardys Kelly, Helen Hayes Hospital
- Investigators
- Marie A. Kelly, DHS, Principal investigator, Helen Hayes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545986
- Sponsor's protocol ID
- 09-04
- Status last verified
- Mar 2012
- First submitted
- 26 Feb 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of High Velocity and Standard Low Velocity Exercise Training on Rehabilitation Outcomes Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01545986
- Acronym / sponsor ID
- 09-04
- Conditions
- Osteoarthritis, Knee
- Keywords
- Joint Replacement, Exercise, Power training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Helen Hayes HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Mar 2012 (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 study was to compare the effects of two exercise programs, using low velocity (LV) and high velocity (HV) contractions, on outcomes of individuals who have undergone total knee arthroplasty (TKA). The experimental hypothesis was that individuals performing HV exercise, compared to LV, would exhibit superior outcomes.
Detailed description
The most effective type of exercise has not been identified for individuals who undergo total knee arthroplasty (TKA). High velocity (HV) exercise when compared to low velocity (LV) exercise produces greater gains in power and certain functional activities in older adults. The use of HV exercise for patients who undergo TKA has not been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Velocity Exercise | Experimental | Behavioral: ExerciseThe high velocity exercise group performed the concentric contraction phase of resisted exercise in one second or less. This group performed sit to stand exercise, walking, curbs, and stairs as fast as was comfortable without an increased limp. Other exercises were performed at the participant preferred rate. |
| Low Velocity exercise | Active comparator | Behavioral: ExerciseThe low velocity exercise group performed the concentric contraction phase of resisted exercise in two seconds. This group performed sit to stand exercise, walking, curbs, stairs, and other exercises at the participant preferred rate. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 60- 89 years of age.
- primary unilateral TKA 10-21 days prior to the outpatient PT evaluation
- received inpatient rehabilitation at Helen Hayes Hospital
Key exclusion criteria (8 listed)
- Any other lower extremity joint or back pain (not inclusive of recent Total knee arthroplasty) rated greater than four out of ten with weight-bearing
- any other lower extremity joint replacement surgery
- diagnosis of osteoporosis with history of fractures, uncontrolled hypertension, unstable cardiac or pulmonary problems, neurological disease affecting motor control, uncontrolled diabetes
- chest pain or shortness of breath on stair-climbing
- requirement of human assistance to walk in addition to the ambulation device
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 |
|---|---|---|
| ExerciseAlso: RehabilitationParticipants attended standardized exercise (ex) sessions twice a week for six weeks for 12 sessions. Group speed differed for concentric contractions, sit to stand ex, walking, curbs, and stairs. The low velocity ex group performed a concentric contraction in two seconds, and high velocity group in one second or less. End range concentric hold, eccentric contraction, repetition (rep) rest and set rest were the same. Open chain ex was performed at 50% of one Repetition Maximum (RM) x 10 reps x one set and then 80% of 1RM x 10 reps x two sets. Curb height and 1RM was assessed at the first, fifth and ninth sessions. Manual stretching, balance ex, sit to stand support, level of aerobic ex, gait training, and functional training were assessed and progressed at any session. | Behavioural | High Velocity Exercise, Low Velocity exercise |
Primary outcome
Change from Baseline in Six Minute Walk Test (6MWT) at six weeks
Time frame: 6 weeks
The distance walked in six minutes is measured for the 6MWT. A 150 foot hallway is used for the test. Standardized instructions are read to the participant. The participant is asked to walk as fast as he/she feels comfortable and safe in order to walk far as he/she can during six minutes. Distance is recorded in feet and later is converted to meters.
6 secondary outcomes
Gait Abnormality Rating Scale (GARS)
Time frame: 6 weeks
Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks
Time frame: 6 weeks
Change from Baseline in Timed Up and Go Test (TUG) at six weeks
Time frame: 6 weeks
Gait Velocity
Time frame: 6 weeks
Change from Baseline in Short Form-36 (SF-36) at six weeks
Time frame: 6 weeks
Change from Baseline in Stair Climb Test at six weeks
Time frame: 6 weeks
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 7 Mar 2012.
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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.
Marie A. Kelly, DHS principal investigator
Helen Hayes Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Osteoarthritis, Knee, run by Helen Hayes Hospital 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 3 inclusion and 8 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 7 Mar 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change from Baseline in Six Minute Walk Test (6MWT) at six weeks (time frame: 6 weeks). 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 7 Mar 2012.