OsteoarthritisPTOA-ECCNCT02098096
Negative Work Exercise for the Treatment of Knee Arthritis
A study testing Negative Work and Stretching in people with Osteoarthritis and Arthritis, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). "Negative work" is the force produced by muscles as they lengthen, and regularly occurs with common activities such as lowering an object from a shelf or walking down stairs. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Osteoarthritis, Arthritis
- What is being tested?
- Negative Work and Stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2019
- 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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men 50 y.o. 70 years old will be recruited for this proposed study.
- Participant inclusion criteria includes having bilateral knee OA (Kellgren-Lawrence Grade 2 or 3) and sedentary (e.g., have not engaged in 3 exercise sessions per week for 3 consecutive months).
- Gait aides and orthoses will not preclude participation in this study.
Who cannot join
- Exclusion criteria include uncontrolled cardiovascular disease, non-ambulatory status, neurogenic weakness, knee extensor and flexor manual muscle test < 3 out of 5, lower extremity amputation, and current participation in a supervised exercise program.
- In addition, major surgical procedures within the last six months, unstable joints, endocrine or metabolic disorders that result in excessive fatigue or muscle weakness, or use of medications that may impair exercise tolerance would also preclude participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
Official title: Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee
The purpose of this study is to develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). "Negative work" is the force produced by muscles as they lengthen, and regularly occurs with common activities such as lowering an object from a shelf or walking down stairs. In this study, the investigators are examining the effectiveness of negative work exercise over a 12-week period in older, male, Veterans.
Read the detailed description
Purpose: To develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). Given that the medical management of chronic PTOA is similar to idiopathic OA, the investigators propose a randomized, clinical trial to pilot negative work exercise in Veterans with knee OA as a proof-of-concept study for a subsequent investigation for people with PTOA.
Research Setting: DC VAMC, Physical Medicine \& Rehabilitation Laboratory
Participants: Men between the ages of 50 and 70 years with a history of bilateral knee osteoarthritis will be consecutively recruited from the DC VAMC Rheumatology Service, Geriatrics Service, and Primary Care Medical Service.
Implications/Significance: The use of negative work exercise to enhance the force attenuation properties of muscle is an innovative approach to the treatment of OA and PTOA, and represents a significant departure from previous rehabilitation studies concerning arthritis. Use of a negative work paradigm may prove to be beneficial for older Veterans with OA and active military personnel with PTOA since similar muscle mechanics are involved in the energy absorption at the knee joint during gait. Despite the functional importance of lengthening muscle actions in protecting weight-bearing joints affected by arthritis, the authors are not aware of a study that involves the sole use of a negative work intervention for OA or PTOA. Addressing the aims of this proposal would lay the ground work needed to justify larger clinical trials featuring the negative work paradigm for soldiers with PTOA.
- Conditions
- Osteoarthritis, Arthritis
- Being tested
- Negative Work, Stretching
- Keywords
- knee, arthritis, Veterans, strength, exercise, muscle
- Medical subject headings
- Osteoarthritis, Arthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative WorkOther
Also called Eccentric exercise
Exercise will be performed twice per week for 12 weeks and exercise intensity will be progressed in three phases. These phases are:
- Familiarization
- Acclimatization
- Progression
Exercise volume will be 3 sets of 10 repetitions (progressing to 4 sets at Week 6) for the knee flexors and extensors.
All exercise will be supervised by a physical therapist and performed on a Biodex isokinetic dynamometer.
StretchingOther
Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Negative Work | Experimental | Negative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks. Receives: Other: Negative Work |
| Stretching | Placebo comparator | A home exercise program consisting of stretches for the major lower extremity muscles groups will be performed twice per week for 12 weeks. Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Voluntary Contraction (MVC; ft-lbs)
Isokinetic assessment of MVC for the knee extensors and flexors.
Measured: 12 weeks
Muscle thickness (cm)
Diagnostic ultrasound assessment of the rectus femoris
Measured: 12 weeks
Secondary outcomes (4)
Step Up/Over Test (movement time (s); kinetics (force indices)
The Step Up/Over Test involves stepping over an 8'' block with the use of a force plate. We will assess concentric force upon ascent, and eccentric force upon descent; the symmetry of these forces will be expressed as an index.
Measured: 12 weeks
Physical Performance Test (PPT-7)
The PPT-7 is a performance-based assessment of function validated for use in older adults. Participant scores will be compared to reference, age-matched, data.
Measured: 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS; English version LK1.0)
Knee OA-specific questionnaire concerning mobility and health-related quality of life changes over time. Participant scores will be compared to a normative comparison group, and the published minimal detectable change scores as validated for a knee OA reference group.
Measured: 12 weeks
Visual Analog Scale for Pain (VAS; 0-10)
VAS will be assessed using a pressure algometer at the mid-thigh before and after negative work exercise.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Michael Harris-Love, DSc, Principal investigator, Washington DC VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098096
- Sponsor's protocol ID
- MIRB01625
- Acronym
- PTOA-ECC
- Status last verified
- Sep 2018
- First submitted
- 19 Mar 2014
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Harris-Love MO. Safety and efficacy of submaximal eccentric strength training for a subject with polymyositis. Arthritis Rheum. 2005 Jun 15;53(3):471-4. doi: 10.1002/art.21185. No abstract available.
PubMed 15934111Hernandez HJ, McIntosh V, Leland A, Harris-Love MO. Progressive Resistance Exercise with Eccentric Loading for the Management of Knee Osteoarthritis. Front Med (Lausanne). 2015 Jul 9;2:45. doi: 10.3389/fmed.2015.00045. eCollection 2015.
PubMed 26217665
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Negative Work Exercise Regimen as an Intervention for Posttraumatic Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02098096
- Acronym / sponsor ID
- PTOA-ECC / MIRB01625
- Conditions
- Osteoarthritis, Arthritis
- Keywords
- knee, arthritis, Veterans, strength, exercise, muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- Mar 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 27 Mar 2014 (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 is to develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). "Negative work" is the force produced by muscles as they lengthen, and regularly occurs with common activities such as lowering an object from a shelf or walking down stairs. In this study, the investigators are examining the effectiveness of negative work exercise over a 12-week period in older, male, Veterans.
Detailed description
Purpose: To develop a negative work exercise regimen as an intervention for posttraumatic osteoarthritis (PTOA). Given that the medical management of chronic PTOA is similar to idiopathic OA, the investigators propose a randomized, clinical trial to pilot negative work exercise in Veterans with knee OA as a proof-of-concept study for a subsequent investigation for people with PTOA.
Research Setting: DC VAMC, Physical Medicine \& Rehabilitation Laboratory
Participants: Men between the ages of 50 and 70 years with a history of bilateral knee osteoarthritis will be consecutively recruited from the DC VAMC Rheumatology Service, Geriatrics Service, and Primary Care Medical Service.
Implications/Significance: The use of negative work exercise to enhance the force attenuation properties of muscle is an innovative approach to the treatment of OA and PTOA, and represents a significant departure from previous rehabilitation studies concerning arthritis. Use of a negative work paradigm may prove to be beneficial for older Veterans with OA and active military personnel with PTOA since similar muscle mechanics are involved in the energy absorption at the knee joint during gait. Despite the functional importance of lengthening muscle actions in protecting weight-bearing joints affected by arthritis, the authors are not aware of a study that involves the sole use of a negative work intervention for OA or PTOA. Addressing the aims of this proposal would lay the ground work needed to justify larger clinical trials featuring the negative work paradigm for soldiers with PTOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Work | Experimental | Other: Negative WorkNegative work exercise via isokinetic knee extension/flexion will be performed twice per week for 12 weeks. |
| Stretching | Placebo comparator | Other: StretchingA home exercise program consisting of stretches for the major lower extremity muscles groups will be performed twice per week for 12 weeks. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men 50 y.o. 70 years old will be recruited for this proposed study.
- Participant inclusion criteria includes having bilateral knee OA (Kellgren-Lawrence Grade 2 or 3) and sedentary (e.g., have not engaged in 3 exercise sessions per week for 3 consecutive months).
- Gait aides and orthoses will not preclude participation in this study.
Key exclusion criteria (2 listed)
- Exclusion criteria include uncontrolled cardiovascular disease, non-ambulatory status, neurogenic weakness, knee extensor and flexor manual muscle test < 3 out of 5, lower extremity amputation, and current participation in a supervised exercise program.
- In addition, major surgical procedures within the last six months, unstable joints, endocrine or metabolic disorders that result in excessive fatigue or muscle weakness, or use of medications that may impair exercise tolerance would also preclude participation in this study.
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 |
|---|---|---|
| Negative WorkAlso: Eccentric exerciseExercise will be performed twice per week for 12 weeks and exercise intensity will be progressed in three phases. These phases are: 1. Familiarization 2. Acclimatization 3. Progression Exercise volume will be 3 sets of 10 repetitions (progressing to 4 sets at Week 6) for the knee flexors and extensors. All exercise will be supervised by a physical therapist and performed on a Biodex isokinetic dynamometer. | Other | Negative Work |
| StretchingHome exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period. | Other | Stretching |
Primary outcome
Maximum Voluntary Contraction (MVC; ft-lbs)
Time frame: 12 weeks
Isokinetic assessment of MVC for the knee extensors and flexors.
Muscle thickness (cm)
Time frame: 12 weeks
Diagnostic ultrasound assessment of the rectus femoris
4 secondary outcomes
Step Up/Over Test (movement time (s); kinetics (force indices)
Time frame: 12 weeks
Physical Performance Test (PPT-7)
Time frame: 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS; English version LK1.0)
Time frame: 12 weeks
Visual Analog Scale for Pain (VAS; 0-10)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Background: PubMed 15934111Harris-Love MO. Safety and efficacy of submaximal eccentric strength training for a subject with polymyositis. Arthritis Rheum. 2005 Jun 15;53(3):471-4. doi: 10.1002/art.21185. No abstract available.
- Background: PubMed 26217665Hernandez HJ, McIntosh V, Leland A, Harris-Love MO. Progressive Resistance Exercise with Eccentric Loading for the Management of Knee Osteoarthritis. Front Med (Lausanne). 2015 Jul 9;2:45. doi: 10.3389/fmed.2015.00045. eCollection 2015.
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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.
Michael Harris-Love, DSc principal investigator
Washington DC VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Work and Stretching in people with Osteoarthritis and Arthritis, run by Washington D.C. Veterans Affairs Medical Center 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 2 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: status not confirmed, as of the sponsor's last update on 20 Sep 2018. 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.
Are results available for this study?
Results are not available in the source record.
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?
Maximum Voluntary Contraction (MVC; ft-lbs) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098096, which also lists 2 linked publications.
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 20 Sep 2018.