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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL122846-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This proposed study will determine whether a home-based exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD, compared to an attention control group and compared to a high intensity exercise intervention. In our secondary aims, we will determine whether high intensity exercise improves six-minute walk distance as compared to the attention control group. In secondary aims, we will also determine whether low intensity exercise and high intensity home-based exercise, respectively, improve patient reported outcomes, physical activity, and treadmill walking performance compared to attention control. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.
We will randomize 305 PAD participants to one of three parallel arms: Group 1: Low-intensity, self-paced walking exercise; Group 2: Standard high intensity, ischemic pain-inducing walking exercise; Group 3: Non-exercising attention control group. The low and high intensity exercise groups will attend center-based exercise sessions once per week for four weeks followed by transition to an entirely home-based exercise program for an additional 48 weeks (52 weeks total). Coaches will contact participants weekly by telephone after the first four weeks of the intervention. The low and high intensity exercise interventions will use identical self-regulatory and support strategies. However, the low intensity exercise group will be instructed to exercise with minimal to no ischemic leg discomfort and the high intensity group will be instructed to exercise to maximal ischemic leg pain. These two distinct exercise prescriptions will be reinforced during 48 weeks of home-based exercise, using a well-validated behavioral coaching model that can be delivered by telephone once weekly. Our primary outcome is change in six-minute walk distance at 52-week follow-up. If our hypotheses are correct, millions of people with PAD will benefit from this alternative exercise regimen which will be accessible to most of the 8 million people in the U.S. who suffer from PAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Low-intensity, self-paced walking exercise. Home based exercise. |
|
| Group 2 | Experimental | Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise. |
|
| Group 3 | Active Comparator | Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute Walk Distance | In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded. | change from baseline to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute Walk Distance | In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded. | change from baseline to week 26 |
| Maximal Treadmill Walking Time |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment | We will use qualitative methods to explore participants' perceptions of the exercise interventions in the high and low-intensity exercise groups, respectively. | At 52 week follow up |
| Physical Activity Levels Over Seven Days |
Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows. First, an ABI < or = 0.90 at the baseline study visit is a well-accepted standard for the diagnosis of PAD and will be an inclusion criterion. Second, people with an ABI of >0.90 and < or = 1.00 who experience a 20% ankle systolic pressure drop after the heel-rise test will also be included. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible. In addition to meeting a criterion for PAD, all participants must be symptomatic, defined by one of the following criteria:; a) ischemic leg symptoms (primarily assessed with the San Diego Claudication Questionnaire); b) report ischemic leg symptoms at the end of the six-minute walk; c) report ischemic leg symptoms at the end of the baseline treadmill stress test; d) walking impairment questionnaire results, e) interview with the potential participant about the presence and nature of leg symptoms during walking activity.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary McDermott, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Ochsner Baptist, Tulane University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42035974 | Derived | McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Apr 24;300:107450. doi: 10.1016/j.ahj.2026.107450. Online ahead of print. | |
| 40020770 | Derived | Whipple MO, Xu S, Zhang D, Guralnik JM, Spring B, Tian L, Treat-Jacobson D, Zhao L, Criqui MH, McDermott MM. Home-Based Exercise and Patient-Reported Outcome Measures in Peripheral Artery Disease: The LITE Randomized Clinical Trial. Am J Cardiol. 2025 Jun 1;244:41-47. doi: 10.1016/j.amjcard.2025.02.027. Epub 2025 Feb 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Low-intensity, self-paced walking exercise. Home based exercise. Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. |
| FG001 | Group 2 | Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise. Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. |
| FG002 | Group 3 | Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise. Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Low-intensity, self-paced walking exercise. Home based exercise. Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Six-minute Walk Distance | In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded. | Posted | Least Squares Mean | 95% Confidence Interval | meters | change from baseline to week 52 |
|
Adverse event data were collected monthly through out the 12-month intervention period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Low-intensity, self-paced walking exercise. Home based exercise. Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower extremity revascularization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New or increased chest discomfort during activity or exercise | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary McDermott MD | Northwestern University | 312-503-6419 | mdm608@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2021 | Oct 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Individuals collecting the outcome assessment will not be aware of group assignment.
|
| Attention control | Other | Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic. |
|
In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Time walked is recorded |
| change from baseline to week 52 |
| Physical Activity Levels | ActiGraph measured physical activity | Change from baseline to week 52 |
| Walking Impairment Questionnaire (WIQ) Distance and Speed Score. | The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed. | change from baseline to week 52 |
| Health-related Quality of Life Measure | The SF-36 physical functioning score will be used to measure quality of life. | change from baseline to week 52 |
| Adherence to Intervention | Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention. | from baseline to week 52 |
| Change in Muscle Biopsy Measures of Mitochondrial Oxidative Metabolism and Oxidative Stress. | Muscle tissue will be collected at baseline and follow up to measures Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress. | change from baseline to week 52 |
ActiGraph
| 26 week follow-up. |
| WIQ Distance and Speed Score | The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed. | 26 week follow-up |
| Health Related Quality of Life | SF-36 physical functioning score. | 26 weeks |
| Adherence to Assigned Intervention | Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention. | 26 weeks. |
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| 35894088 | Derived | Hammond MM, Spring B, Rejeski WJ, Sufit R, Criqui MH, Tian L, Zhao L, Xu S, Kibbe MR, Leeuwenburgh C, Manini T, Forman DE, Treat-Jacobson D, Polonsky TS, Bazzano L, Ferrucci L, Guralnik J, Lloyd-Jones DM, McDermott MM. Effects of Walking Exercise at a Pace With Versus Without Ischemic Leg Symptoms on Functional Performance Measures in People With Lower Extremity Peripheral Artery Disease: The LITE Randomized Clinical Trial. J Am Heart Assoc. 2022 Aug 2;11(15):e025063. doi: 10.1161/JAHA.121.025063. Epub 2022 Jul 27. |
| 33829920 | Derived | Slysz JT, Rejeski WJ, Treat-Jacobson D, Bazzano LA, Forman DE, Manini TM, Criqui MH, Tian L, Zhao L, Zhang D, Guralnik JM, Ferrucci L, Kibbe MR, Polonsky TS, Spring B, Sufit R, Leeuwenburgh C, McDermott MM. Sustained physical activity in peripheral artery disease: Associations with disease severity, functional performance, health-related quality of life, and subsequent serious adverse events in the LITE randomized clinical trial. Vasc Med. 2021 Oct;26(5):497-506. doi: 10.1177/1358863X21989430. Epub 2021 Apr 8. |
| 33821898 | Derived | McDermott MM, Spring B, Tian L, Treat-Jacobson D, Ferrucci L, Lloyd-Jones D, Zhao L, Polonsky T, Kibbe MR, Bazzano L, Guralnik JM, Forman DE, Rego A, Zhang D, Domanchuk K, Leeuwenburgh C, Sufit R, Smith B, Manini T, Criqui MH, Rejeski WJ. Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1266-1276. doi: 10.1001/jama.2021.2536. |
| BG001 |
| Group 2 |
Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise. Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. |
| BG002 | Group 3 | Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise. Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ankle-brachial index | Mean | Standard Deviation | ratio |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Six-min walk distance | Mean | Standard Deviation | meters |
|
Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise.
Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
| OG002 | Group 3 | Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise. Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic. |
|
|
| Secondary | Six-minute Walk Distance | In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded. | Not Posted | change from baseline to week 26 | Participants |
| Secondary | Maximal Treadmill Walking Time | In the treadmill walking test, participants walk on either a gardner or modified gardner protocol until they stop the test. Time walked is recorded | Not Posted | change from baseline to week 52 | Participants |
| Secondary | Physical Activity Levels | ActiGraph measured physical activity | Not Posted | Change from baseline to week 52 | Participants |
| Secondary | Walking Impairment Questionnaire (WIQ) Distance and Speed Score. | The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed. | Not Posted | change from baseline to week 52 | Participants |
| Secondary | Health-related Quality of Life Measure | The SF-36 physical functioning score will be used to measure quality of life. | Not Posted | change from baseline to week 52 | Participants |
| Secondary | Adherence to Intervention | Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention. | Not Posted | from baseline to week 52 | Participants |
| Secondary | Change in Muscle Biopsy Measures of Mitochondrial Oxidative Metabolism and Oxidative Stress. | Muscle tissue will be collected at baseline and follow up to measures Change in muscle biopsy measures of mitochondrial oxidative metabolism and oxidative stress. | Not Posted | change from baseline to week 52 | Participants |
| Other Pre-specified | Qualitative Assessment | We will use qualitative methods to explore participants' perceptions of the exercise interventions in the high and low-intensity exercise groups, respectively. | Not Posted | At 52 week follow up | Participants |
| Other Pre-specified | Physical Activity Levels Over Seven Days | ActiGraph | Not Posted | 26 week follow-up. | Participants |
| Other Pre-specified | WIQ Distance and Speed Score | The WIQ is a well validated questionnaire that measures patient-reported walking limitations in distance and speed. | Not Posted | 26 week follow-up | Participants |
| Other Pre-specified | Health Related Quality of Life | SF-36 physical functioning score. | Not Posted | 26 weeks | Participants |
| Other Pre-specified | Adherence to Assigned Intervention | Adherence is defined as the proportion achieving at least 80% of the prescribed exercise frequency and duration during the final month of the intervention. | Not Posted | 26 weeks. | Participants |
| 2 |
| 116 |
| 43 |
| 116 |
| 34 |
| 116 |
| EG001 | Group 2 | Standard high intensity, ischemic pain-inducing walking exercise. Home based exercise. Exercise: Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach. | 2 | 124 | 40 | 124 | 42 | 124 |
| EG002 | Group 3 | Non-exercising attention control group. Contact with staff at same frequency as exercise groups, but staff deliver information on health not related to exercise. Attention control: Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic. | 2 | 65 | 19 | 65 | 29 | 65 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Ischemic heart disease | Cardiac disorders | Systematic Assessment |
|
| Abdominal problem | General disorders | Systematic Assessment |
|
| Diabetes | General disorders | Systematic Assessment |
|
| GI bleed | General disorders | Systematic Assessment |
|
| Critical limb ischemia | Vascular disorders | Systematic Assessment |
|
| Fall or fracture | General disorders | Systematic Assessment |
|
| Pulmonary event | General disorders | Systematic Assessment |
|
| Stroke or cerebral hemorrhage | Cardiac disorders | Systematic Assessment |
|
| Elective surgery | General disorders | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Arrhythmia | General disorders | Systematic Assessment |
|
| Coronary revascularization | General disorders | Systematic Assessment |
|
| Heart failure | Cardiac disorders | Systematic Assessment |
|
| Lightheaded | General disorders | Systematic Assessment |
|
| Venous thromboembolism | General disorders | Systematic Assessment |
|
| Carotid revascularization | Cardiac disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Hypertension | General disorders | Systematic Assessment |
|
| Abdominal infection | General disorders | Systematic Assessment |
|
| Acute renal failure | General disorders | Systematic Assessment |
|
| Bronchitis | General disorders | Systematic Assessment |
|
| Cancer | General disorders | Systematic Assessment |
|
| Colitis | General disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Esophageal problem | General disorders | Systematic Assessment |
|
| PAD | General disorders | Systematic Assessment |
|
| Angina | General disorders | Systematic Assessment |
|
| Bowel obstruction | General disorders | Systematic Assessment |
|
| Complication from angiogram | General disorders | Systematic Assessment |
|
| Complication from medical procedure | General disorders | Systematic Assessment |
|
| Congestive heart failure | General disorders | Systematic Assessment |
|
| Diagnostic testing | General disorders | Systematic Assessment |
|
| Electrolyte problem | General disorders | Systematic Assessment |
|
| Medication side effect | General disorders | Systematic Assessment |
|
| Mental status | General disorders | Systematic Assessment |
|
| Musculoskeletal | General disorders | Systematic Assessment |
|
| Neurologic problem | General disorders | Systematic Assessment |
|
| Pleural effusions | General disorders | Systematic Assessment |
|
| Psychiatric | General disorders | Systematic Assessment |
|
| Testicular problem | General disorders | Systematic Assessment |
|
| Ulcer | General disorders | Systematic Assessment |
|
| Weight loss | General disorders | Systematic Assessment |
|
| New or increased shortness of breath during activity or exercise | General disorders | Systematic Assessment |
|
| New or increased dizziness or generalized weakness during activity or exercise | General disorders | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |