NCT01545986

Brief 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). The experimental hypothesis was that individuals performing HV exercise, compared to LV, would exhibit superior outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

2.2 years

First QC Date

February 26, 2012

Last Update Submit

March 1, 2012

Conditions

Keywords

Joint ReplacementExercisePower training

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (6)

  • Gait Abnormality Rating Scale (GARS)

    6 weeks

  • Change from Baseline in Visual Analogue Scale (VAS) Pain at six weeks

    6 weeks

  • Change from Baseline in Timed Up and Go Test (TUG) at six weeks

    6 weeks

  • Gait Velocity

    6 weeks

  • Change from Baseline in Short Form-36 (SF-36) at six weeks

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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.

Also known as: Rehabilitation
High Velocity ExerciseLow Velocity exercise

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Hayes Hospital

West Haverstraw, New York, 10993, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

ExerciseRehabilitation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marie A. Kelly, DHS

    Helen Hayes Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 7, 2012

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations