Peripheral Arterial DiseaseNCT01970332
Mechanisms That Produce the Leg Dysfunction of Claudication & Treatment Strategies
A study testing Revascularization Surgery and Supervised exercise therapy in people with Peripheral Arterial Disease, run by University of Nebraska at 1 site in United States.
Trial summary
Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Revascularization Surgery and Supervised exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 30 May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a positive history of chronic claudication
- exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon
- an ankle/brachial index < 0.90 at rest
Who cannot join
- absence of Peripheral Arterial Disease (PAD)
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center, Omaha
Omaha, Nebraska, 68105
About this study
Official title: Mitochondrial Dysfunction, Oxidative Damage and Inflammation in Claudication
Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.
Read the detailed description
Claudication, defined as walking-induced leg discomfort and gait dysfunction relieved by rest, affects 5% of Americans over 55 years of age. Claudicating patients adopt sedentary lifestyles and cluster at the extreme low end of the physical activity spectrum, escalating risk for adverse health effects. The primary therapeutic goals for claudicating patients are restoration of leg function and prevention of disease progression. Current, rehabilitative interventions focus on inadequate blood flow as the only cause of claudication. Operative revascularization and/or exercise therapy are the principal conventional therapeutic modalities, providing only modest rehabilitative benefit. Applying biomechanical analysis to gait of claudicating patients, the investigators team has developed preliminary data indicating that blood flow is not the only mechanism producing the limb dysfunction of claudication. Several laboratories including the investigators own have demonstrated a myopathy, characterized by mitochondrial dysfunction, oxidative damage and inflammation, in leg skeletal muscle of claudicating patients. These conditions have not been quantified, comprehensively, in relation to claudication, and their association with severity of claudication is not known. The investigators hypothesis is that blood flow restriction is not a good predictor of limb dysfunction in claudication, whereas muscle mitochondrial dysfunction, oxidative damage and inflammation are strong predictors of limb dysfunction both at baseline and after conventional therapy with revascularization or supervised exercise. Under Aim #1, the investigators will acquire precise measurements of gastrocnemius mitochondrial function, oxidative damage and inflammation in claudicating patients, at the time of their initial presentation, and evaluate these measurements as predictors of objective measures of limb function and subjective measures of quality of life. Under Aims #2 and #3, the investigators will evaluate the effects of revascularization (Aim#2) and supervised exercise therapy (Aim#3) on mitochondrial dysfunction, oxidative damage and inflammation in claudicating gastrocnemius and on objective measures of limb function and subjective measures of quality of life. If the investigators hypothesis is correct, the work in Aim #2 will for the first time definitively demonstrate that blood flow restriction due to blockages in the arterial tree is not the only cause of claudication. The work under Aims #2 and #3 will determine whether revascularization or exercise therapy has a beneficial effect on the myopathy of claudicating muscle with associated improvement in limb function and quality of life. Finally, the proposed studies under Aims #1, #2 and #3 will provide quantitative modeling of a panel of mechanistic (bioenergetics, oxidative stress and inflammation) parameters as predictors of objective measurements of claudicating limb function and subjective measures of quality of life commonly used for clinical assessment. Measurements of gastrocnemius mitochondrial function, oxidative damage and inflammation may be useful tools that permit staging of disease for optimum intervention and evaluation of therapeutic interventions that specifically target these conditions, improving rehabilitative outcomes.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Revascularization Surgery, Supervised exercise therapy
- Keywords
- Peripheral Arterial Disease, Peripheral Vascular Disease, Claudication, Myopathy, Oxidative stress, Mitochondrial dysfunction, Biomechanics, Inflammation
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Intermittent Claudication, Muscular Diseases, Mitochondrial Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization SurgeryProcedure or surgery
Supervised exercise therapyOther
| Study group | Role | What they receive |
|---|---|---|
| No Exercise Therapy or Revascularization operation | No intervention | The patient is evaluated but no intervention |
| Revascularization Surgery | Experimental | The patient undergoes surgery to revascularize the ischemic, symptomatic limb(s) Receives: Other: Supervised exercise therapy |
| Exercise Therapy | Experimental | The patient undergoes supervised exercise therapy for 6 months Receives: Procedure: Revascularization Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distances
Initial Claudication Distance, Absolute Claudication Distance, 6-Minute Walking Distance
Measured: six months
Quality of life Questionnaires
Walking Impairment Questionnaire and the Medical Outcomes Study Short Form 36 Healthy Survey
Measured: six months
Leg biomechanics
Propulsion Impulse, Ankle plantarflexor torque, Ankle plantarflexor power and maximum isometric plantarflexion force
Measured: six months
Leg hemodynamics
Ankle Brachial Index
Measured: 6 months
Secondary outcomes (4)
Myofiber Mitochondrial Function
Mitochondrial Respiration measured via polarography
Measured: 6 months
Myofiber Oxidative Damage
Myofiber content of HNE adducts and protein carbonyls. Muscle Manganese Superoxide Dismutase activity
Measured: 6 months
Muscle inflammation
Expression of pro- and anti-inflammatory cytokines and monocyte/macrophage cell counts.
Measured: 6 months
Myofiber Morphology
Cross-sectional area of the myofibers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study start1 Sep 2010
- Primary completion30 May 2016
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), American Heart Association
- Responsible party
- Sponsor
- Investigators
- Iraklis I Pipinos, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970332
- Sponsor's protocol ID
- 0510-10-ET
- Other IDs
- 5R01AG034995, 15POST25520004
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2013
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahman H, Leutzinger T, Hassan M, Schieber M, Koutakis P, Fuglestad MA, DeSpiegelaere H, Longo GM, Malcolm P, Johanning JM, Casale GP, Pipinos II, Myers SA. Peripheral artery disease causes consistent gait irregularities regardless of the location of leg claudication pain. Ann Phys Rehabil Med. 2024 Apr;67(3):101793. doi: 10.1016/j.rehab.2023.101793. Epub 2023 Dec 20.
PubMed 38118246
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Dysfunction, Oxidative Damage and Inflammation in Claudication
- ClinicalTrials.gov ID
- NCT01970332
- Acronym / sponsor ID
- 0510-10-ET
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Peripheral Vascular Disease, Claudication, Myopathy, Oxidative stress, Mitochondrial dysfunction, Biomechanics, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), American Heart Association
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 28 Oct 2013 (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.
Intermittent claudication afflicts 5% of the US population older than 55 years of age and develops along with hardening of the arteries of the legs. Claudicating patients limp and can only walk very short distances because their legs hurt. This protocol evaluates the mechanisms that may produce the leg dysfunction of claudication and its successful completion can ultimately produce significant new diagnostic and treatment strategies for the care of claudicating patients.
Detailed description
Claudication, defined as walking-induced leg discomfort and gait dysfunction relieved by rest, affects 5% of Americans over 55 years of age. Claudicating patients adopt sedentary lifestyles and cluster at the extreme low end of the physical activity spectrum, escalating risk for adverse health effects. The primary therapeutic goals for claudicating patients are restoration of leg function and prevention of disease progression. Current, rehabilitative interventions focus on inadequate blood flow as the only cause of claudication. Operative revascularization and/or exercise therapy are the principal conventional therapeutic modalities, providing only modest rehabilitative benefit. Applying biomechanical analysis to gait of claudicating patients, the investigators team has developed preliminary data indicating that blood flow is not the only mechanism producing the limb dysfunction of claudication. Several laboratories including the investigators own have demonstrated a myopathy, characterized by mitochondrial dysfunction, oxidative damage and inflammation, in leg skeletal muscle of claudicating patients. These conditions have not been quantified, comprehensively, in relation to claudication, and their association with severity of claudication is not known. The investigators hypothesis is that blood flow restriction is not a good predictor of limb dysfunction in claudication, whereas muscle mitochondrial dysfunction, oxidative damage and inflammation are strong predictors of limb dysfunction both at baseline and after conventional therapy with revascularization or supervised exercise. Under Aim #1, the investigators will acquire precise measurements of gastrocnemius mitochondrial function, oxidative damage and inflammation in claudicating patients, at the time of their initial presentation, and evaluate these measurements as predictors of objective measures of limb function and subjective measures of quality of life. Under Aims #2 and #3, the investigators will evaluate the effects of revascularization (Aim#2) and supervised exercise therapy (Aim#3) on mitochondrial dysfunction, oxidative damage and inflammation in claudicating gastrocnemius and on objective measures of limb function and subjective measures of quality of life. If the investigators hypothesis is correct, the work in Aim #2 will for the first time definitively demonstrate that blood flow restriction due to blockages in the arterial tree is not the only cause of claudication. The work under Aims #2 and #3 will determine whether revascularization or exercise therapy has a beneficial effect on the myopathy of claudicating muscle with associated improvement in limb function and quality of life. Finally, the proposed studies under Aims #1, #2 and #3 will provide quantitative modeling of a panel of mechanistic (bioenergetics, oxidative stress and inflammation) parameters as predictors of objective measurements of claudicating limb function and subjective measures of quality of life commonly used for clinical assessment. Measurements of gastrocnemius mitochondrial function, oxidative damage and inflammation may be useful tools that permit staging of disease for optimum intervention and evaluation of therapeutic interventions that specifically target these conditions, improving rehabilitative outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Exercise Therapy or Revascularization operation | No intervention | –The patient is evaluated but no intervention |
| Revascularization Surgery | Experimental | Other: Supervised exercise therapyThe patient undergoes surgery to revascularize the ischemic, symptomatic limb(s) |
| Exercise Therapy | Experimental | Procedure: Revascularization SurgeryThe patient undergoes supervised exercise therapy for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a positive history of chronic claudication
- exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon
- an ankle/brachial index < 0.90 at rest
Key exclusion criteria (3 listed)
- absence of Peripheral Arterial Disease (PAD)
- acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology
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 |
|---|---|---|
| Revascularization Surgery | Procedure or surgery | Exercise Therapy |
| Supervised exercise therapy | Other | Revascularization Surgery |
Primary outcome
Walking distances
Time frame: six months
Initial Claudication Distance, Absolute Claudication Distance, 6-Minute Walking Distance
Quality of life Questionnaires
Time frame: six months
Walking Impairment Questionnaire and the Medical Outcomes Study Short Form 36 Healthy Survey
Leg biomechanics
Time frame: six months
Propulsion Impulse, Ankle plantarflexor torque, Ankle plantarflexor power and maximum isometric plantarflexion force
Leg hemodynamics
Time frame: 6 months
Ankle Brachial Index
4 secondary outcomes
Myofiber Mitochondrial Function
Time frame: 6 months
Myofiber Oxidative Damage
Time frame: 6 months
Muscle inflammation
Time frame: 6 months
Myofiber Morphology
Time frame: 6 months
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 Sep 2023.
- Derived from this study: PubMed 38118246Rahman H, Leutzinger T, Hassan M, Schieber M, Koutakis P, Fuglestad MA, DeSpiegelaere H, Longo GM, Malcolm P, Johanning JM, Casale GP, Pipinos II, Myers SA. Peripheral artery disease causes consistent gait irregularities regardless of the location of leg claudication pain. Ann Phys Rehabil Med. 2024 Apr;67(3):101793. doi: 10.1016/j.rehab.2023.101793. Epub 2023 Dec 20.
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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.
Iraklis I Pipinos, MD, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization Surgery and Supervised exercise therapy in people with Peripheral Arterial Disease, run by University of Nebraska 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 3 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 Sep 2023. 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?
Walking distances (time frame: six months). The study lists 4 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 NCT01970332, which also lists 1 linked publication.
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 Sep 2023.