A Comparative Analysis of Two Types of Exercise on Outcomes Following Total Knee Arthroplasty

March 1, 2012 updated by: Marie A. Kardys Kelly, Helen Hayes Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • West Haverstraw, New York, United States, 10993
        • Helen Hayes Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Velocity Exercise
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.
Behavioral: Exercise
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.
Other Names:
  • Rehabilitation
Active Comparator: Low Velocity exercise
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.
Behavioral: Exercise
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.
Other Names:
  • Rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait Abnormality Rating Scale (GARS)
Time Frame: 6 weeks
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.
6 weeks
Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks
Time Frame: 6 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.
6 weeks
Change from Baseline in Timed Up and Go Test (TUG) at six weeks
Time Frame: 6 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.
6 weeks
Gait Velocity
Time Frame: 6 weeks
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.
6 weeks
Change from Baseline in Short Form-36 (SF-36) at six weeks
Time Frame: 6 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.
6 weeks
Change from Baseline in Stair Climb Test at six weeks
Time Frame: 6 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helen Hayes Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie A. Kelly, DHS, Helen Hayes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-04

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