Peripheral Arterial DiseaseEarly Phase 1NCT03478085
Near-Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease
A Early Phase 1 study testing Oxygen guided exercise therapy in people with Peripheral Arterial Disease, run by Augusta University.
Trial summary
Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have limited therapeutic options to improve claudication. Supervised exercise programs are generally effective in improving leg pain from walking, but are poorly adhered to because of patient discomfort. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Oxygen guided exercise therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 31 May 2016
- Phase
- Early Phase 1
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects
- Clinically stable symptoms of intermittent claudication from PAD (with no change in symptom severity in the 2 months prior to screening.)
- On stable medical therapy for previous 3 months.
- Able to achieve Total Walking Time (TWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol.
- PAD will be defined by the presence of a Doppler-derived ankle-brachial index (ABI) of < 0.85 in the symptomatic limb after 10 minutes of rest at screening. For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification, or if ABI is > 0.85 to 1.0, and a reduction of 20% in ABI measured within 1 minute of treadmill testing.
Who cannot join
- Critical limb ischemia either chronic (category 3 and 4 of SVS classification) or acute ischemia manifested by rest pain, ulceration, or gangrene;
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Unstable angina, myocardial infarction, transient ischemic attack, stroke or revascularization in the preceding 4 months;
- Severe heart failure (Class III or IV);
- Limitation on exercise for symptoms other than intermittent claudication such as arthritis or severe dyspnea;
- Alcohol or drug abuse, or any other disease process that, in the opinion of the PI, will interfere with the ability of the patient to participate in the study.
About this study
Official title: Near Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease
Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have limited therapeutic options to improve claudication. Supervised exercise programs are generally effective in improving leg pain from walking, but are poorly adhered to because of patient discomfort. The benefit of exercise training programs is thought to be mediated in part through repeated ischemic stimuli that activate endogenous regenerative mechanisms. In preliminary studies, exercise-induced tissue desaturation by near infrared spectroscopy (NIRS) precedes the onset of leg pain. This proposal aims to explore a novel strategy of exercise training in PAD based on measured tissue hypoxia rather than pain symptoms using NIRS to non-invasively characterize muscle oxygen tension.
Methods: In subjects with symptomatic peripheral arterial disease, the efficacy of a novel NIRS-based strategy of thrice-weekly exercise training will be assessed. Enrolled subjects will be randomized to NIRS-based training, traditional claudication-based training, or self-directed walking. The hypotheses tested include: 1) NIRS-directed exercise improves claudication to a similar degree as symptom-directed exercise training and 2) is superior to self-directed walking. In the symptom-based group, physical effort will be dictated by claudication symptoms, whereas in the hypoxia-based training program, physical effort is dictated by NIRS measure of calf oxygen tension. Efficacy in the training programs will be evaluated by total walking time on a standard graded treadmill test after 12 weeks. Other measures will be claudication onset time, subjective and objective measures of physical activity, changes in vascular function. In addition, the hypothesis that hypoxia-directed training will result in increased ischemic signaling and increased progenitor cell mobilization to a degree similar as in claudication-based training will be tested.
Conclusions: These experiments will test whether a training strategy based on tissue hypoxia (measured by NIRS) is as effective as and more tolerable than traditional symptom-based training programs in PAD. In addition, these experiments will characterize mechanistic responses to hypoxia that may account for clinical improvements that exercise training affords.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Oxygen guided exercise therapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen guided exercise therapyOther
Subjects exercise to a certain intensity based on 15% muscle oxygen desaturation.
| Study group | Role | What they receive |
|---|---|---|
| Traditional exercise therapy | Active comparator | Training will be performed three times a week for 12 weeks. Each session will take place on a GaitKeeper treadmill (Sammons Preston, IL) treadmill and will last 45 minutes with a 5 minute warm up and cool down of either cycling or walking. Receives: Other: Oxygen guided exercise therapy |
| Oxygen guided exercise therapy | Experimental | Training will be performed three times a week for 12 weeks. Each session will take place on a GaitKeeper treadmill (Sammons Preston, IL) treadmill and will last 45 minutes with a 5 minute warm up and cool down of either cycling or walking. All patients will be outfitted during exercise with the PortaMon NIRS device on the most affected calf (including subjects in the symptom-driven exercise cohort). The intensity of training will be adjusted to either pain (claudication) rating or oxygen tension. In preliminary studies, a 50% reduction in the tissue saturation index is typically not associated with severe claudication and will be used as the lower level threshold to gauge physical effort (i.e., if subjects do not desaturate by >50% then the intensity of training - the walking pace - will be increased). The training duration, intensity, pain rating, and oxygen tension will be recorded. Receives: Other: Oxygen guided exercise therapy |
| Control | Placebo comparator | Patients will be advised to walk independently. Receives: Other: Oxygen guided exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Free Walking Time in Minutes
Time until onset of claudication will be measured in subjects undergoing a Gardner protocol 12 minute walk on a treadmill.
Measured: 12 weeks
Secondary outcomes (1)
Total Treadmill Walking Time in Minutes
Time until onset of claudication will be measured in subjects undergoing a Gardner protocol 12 minute walk on a treadmill.
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 2018
- Study start1 Jun 2013
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478085
- Sponsor's protocol ID
- 13GRNT1693006
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy-Guided Exercise Training in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03478085
- Acronym / sponsor ID
- 13GRNT1693006
- Conditions
- Peripheral Arterial Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 27 Mar 2018 (actual)
- 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.
Background: Patients suffering with atherosclerotic peripheral arterial disease (PAD) have limited therapeutic options to improve claudication. Supervised exercise programs are generally effective in improving leg pain from walking, but are poorly adhered to because of patient discomfort. The benefit of exercise training programs is thought to be mediated in part through repeated ischemic stimuli that activate endogenous regenerative mechanisms. In preliminary studies, exercise-induced tissue desaturation by near infrared spectroscopy (NIRS) precedes the onset of leg pain. This proposal aims to explore a novel strategy of exercise training in PAD based on measured tissue hypoxia rather than pain symptoms using NIRS to non-invasively characterize muscle oxygen tension.
Methods: In subjects with symptomatic peripheral arterial disease, the efficacy of a novel NIRS-based strategy of thrice-weekly exercise training will be assessed. Enrolled subjects will be randomized to NIRS-based training, traditional claudication-based training, or self-directed walking. The hypotheses tested include: 1) NIRS-directed exercise improves claudication to a similar degree as symptom-directed exercise training and 2) is superior to self-directed walking. In the symptom-based group, physical effort will be dictated by claudication symptoms, whereas in the hypoxia-based training program, physical effort is dictated by NIRS measure of calf oxygen tension. Efficacy in the training programs will be evaluated by total walking time on a standard graded treadmill test after 12 weeks. Other measures will be claudication onset time, subjective and objective measures of physical activity, changes in vascular function. In addition, the hypothesis that hypoxia-directed training will result in increased ischemic signaling and increased progenitor cell mobilization to a degree similar as in claudication-based training will be tested.
Conclusions: These experiments will test whether a training strategy based on tissue hypoxia (measured by NIRS) is as effective as and more tolerable than traditional symptom-based training programs in PAD. In addition, these experiments will characterize mechanistic responses to hypoxia that may account for clinical improvements that exercise training affords.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional exercise therapy | Active comparator | Other: Oxygen guided exercise therapyTraining will be performed three times a week for 12 weeks. Each session will take place on a GaitKeeper treadmill (Sammons Preston, IL) treadmill and will last 45 minutes with a 5 minute warm up and cool down of either cycling or walking. |
| Oxygen guided exercise therapy | Experimental | Other: Oxygen guided exercise therapyTraining will be performed three times a week for 12 weeks. Each session will take place on a GaitKeeper treadmill (Sammons Preston, IL) treadmill and will last 45 minutes with a 5 minute warm up and cool down of either cycling or walking. All patients will be outfitted during exercise with the PortaMon NIRS device on the most affected calf (including subjects in the symptom-driven exercise cohort). The intensity of training will be adjusted to either pain (claudication) rating or oxygen tension. In preliminary studies, a 50% reduction in the tissue saturation index is typically not associated with severe claudication and will be used as the lower level threshold to gauge physical effort (i.e., if subjects do not desaturate by >50% then the intensity of training - the walking pace - will be increased). The training duration, intensity, pain rating, and oxygen tension will be recorded. |
| Control | Placebo comparator | Other: Oxygen guided exercise therapyPatients will be advised to walk independently. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects
- Clinically stable symptoms of intermittent claudication from PAD (with no change in symptom severity in the 2 months prior to screening.)
- On stable medical therapy for previous 3 months.
- Able to achieve Total Walking Time (TWT) between 1 and 12 minutes on a standardized Gardner treadmill protocol.
- PAD will be defined by the presence of a Doppler-derived ankle-brachial index (ABI) of < 0.85 in the symptomatic limb after 10 minutes of rest at screening. For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification, or if ABI is > 0.85 to 1.0, and a reduction of 20% in ABI measured within 1 minute of treadmill testing.
Key exclusion criteria (6 listed)
- Critical limb ischemia either chronic (category 3 and 4 of SVS classification) or acute ischemia manifested by rest pain, ulceration, or gangrene;
- Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
- Unstable angina, myocardial infarction, transient ischemic attack, stroke or revascularization in the preceding 4 months;
- Severe heart failure (Class III or IV);
- Limitation on exercise for symptoms other than intermittent claudication such as arthritis or severe dyspnea;
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 |
|---|---|---|
| Oxygen guided exercise therapySubjects exercise to a certain intensity based on 15% muscle oxygen desaturation. | Other | Control, Oxygen guided exercise therapy, Traditional exercise therapy |
Primary outcome
Pain Free Walking Time in Minutes
Time frame: 12 weeks
Time until onset of claudication will be measured in subjects undergoing a Gardner protocol 12 minute walk on a treadmill.
1 secondary outcome
Total Treadmill Walking Time in Minutes
Time frame: 12 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 27 Mar 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxygen guided exercise therapy in people with Peripheral Arterial Disease, run by Augusta University.
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 5 inclusion and 6 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 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Free Walking Time in Minutes (time frame: 12 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 27 Mar 2018.