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| Name | Class |
|---|---|
| Roseguini, Bruno, PhD | INDIV |
| Michael Emery, MD | UNKNOWN |
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The purpose of this study is to investigate whether exposure to heat therapy improves calf muscle oxygenation and enhances walking tolerance in patients with symptomatic Peripheral Arterial Disease (PAD).
Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to establish evidence to support the validity of HT in improving walking tolerance on PAD patents.
Subjects will complete baseline assessments for eligibility, including medical history and ankle-brachial measurement. Eligible participants will be asked to report to the laboratory on 4 different occasions. The purpose of visits 1 and 2 The central hypothesis of this study, based on preliminary data, is that exposure to HT will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. is to familiarize the participants with the treadmill walking test and assess the test-retest reliability of maximal walking time determination. On visits 3 and 4 participants will receive either heat treatment or a control treatment for 80 min prior to undergoing a symptom-limited incremental test on the treadmill.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham, then heat therapy | Experimental | Participants were fitted with liquid-circulating trousers. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the heat therapy (HT) treatment. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. |
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| Heat therapy, then sham | Experimental | Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs after completion of the sham treatment session, participants returned to the laboratory and received the sham treatment. In the sham-treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control/Sham Treatment | Device | Water at 33ºC was circulated through water-circulating trousers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Walking Time | Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT). | Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min |
| Measure | Description | Time Frame |
|---|---|---|
| Claudication Onset Time | Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raghu L Motaganahalli, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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Nineteen participants were consented, but three were withdrawn before receiving an experimental treatment due to the inability to safely and consistently perform the treadmill exercise test. A total of 16 participants completed all study visits.
Participants were identified and contacted by the Indiana Clinical and Translational Science Institute Research Network (ResNet) research assistants. After interest in participation was established, patients were contacted directly by the investigators. Additional study participants were identified by physicians from the Division of Vascular Surgery at Methodist Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham, Then Heat Therapy | Participants were fitted with liquid-circulating trousers. In the sham treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). At least 72 hrs following the completion of the sham treatment, patients returned to the laboratory and underwent the leg heat therapy (HT treatment). In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. |
| FG001 | Heat Therapy, Then Sham | Participants were fitted with liquid-circulating trousers. In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. At least 72 hrs following the completion of the HT treatment, patients returned to the laboratory and underwent the sham treatment. In the sham treatment session, water at 33℃ was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout |
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| Second Intervention |
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Nineteen participants were consented, but three were withdrawn before receiving an experimental treatment due to inability to safely and consistently perform the treadmill exercise test. Baseline clinical characteristics of the 16 participants that completed all study visits are presented.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were assigned, using a randomized, crossover design, to undergo a single session of either a sham treatment (sham) or heat therapy (HT) prior to a symptom-limited cardiopulmonary treadmill exercise test. In the sham treatment session, water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). In the HT session, water at 43℃ was circulated through the tube-lined trousers using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37-38ºC. |
| 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 | Peak Walking Time | Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT). | Posted | Mean | Standard Deviation | seconds | Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min |
|
Throughout the duration of the study (approximately 1 month).
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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 | Sham Treatment | Participants were fitted with liquid-circulating trousers and water at 33°C was circulated through the trousers for 90 min using a water pump (HTP-1500, Adroit Medical, Louden, Tennessee, United States). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Blood and lymphatic system disorders | Non-systematic Assessment | Baseline blood draw indicated that participant had plasma potassium concentration of 2.9 (critical value). The study session was stopped and the patient was escorted to the Emergency Department. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruno Roseguini | Purdue University/Indiana University | 7654962612 | brosegui@purdue.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 | Jan 28, 2022 | Jan 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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Subjects will not be told outright which therapy there are receiving (thermoneutral or HT) and the Cardiologist supervising the exercise test will not be told which therapy was given.
| Heat Therapy (HT) | Device | Water at 42-43ºC was circulated through the water-circulating trousers. |
|
| The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
| Peak Systolic Blood Pressure | Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise. | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
| Peak Diastolic Blood Pressure | Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
| Peak Calf Tissue Saturation Index | The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands). | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
| Post-exercise Plasma Endothelin-1 Concentration | Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R&D Systems, Minneapolis, MN, United States) | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min. Ten minutes following completion of the incremental treadmill test, blood samples were obtained for the assessment of serum ET-1 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Heat Therapy | Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C. |
|
|
| Secondary | Claudication Onset Time | Exercise testing was performed in a motorized treadmill (Pro 27, Woodway, St. Paul, Minnesota, United States) following the Gardner-Skinner protocol, which consists of walking at a constant speed (2 mph) with a 2%-grade increase every 2 min (Gardner et al., 1991). Participants received standardized instructions and were asked to indicate when they first began to feel leg pain with a "thumbs up" signal (defined as COT), and then give a "thumbs down" signal when they could no longer continue with the test (defined as PWT). | Posted | Mean | Standard Deviation | Seconds | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
|
|
|
| Secondary | Peak Systolic Blood Pressure | Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise. | Posted | Mean | Standard Deviation | mmHg | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
|
|
|
| Secondary | Peak Diastolic Blood Pressure | Blood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise | Posted | Mean | Standard Deviation | mmHg | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
|
|
|
| Secondary | Peak Calf Tissue Saturation Index | The tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands). | Posted | Mean | Standard Deviation | % tissue saturation | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min |
|
|
|
| Secondary | Post-exercise Plasma Endothelin-1 Concentration | Commercially available enzyme-linked immunosorbent assay kits were used to measure the plasma concentrations of ET-1 (DET100, Endothelin-1 Quantikine ELISA Kit, R&D Systems, Minneapolis, MN, United States) | Posted | Mean | Standard Deviation | pg/mL | The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 min. Ten minutes following completion of the incremental treadmill test, blood samples were obtained for the assessment of serum ET-1 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Heat Therapy | Participants were fitted with liquid-circulating trousers and water at 43°C was circulated through the tube-lined trousers for 90 min using a heated bath circulator (HT; Aqua Relief Systems, Akron, Ohio, United States) with the goal of increasing leg skin temperature to 37°C-38°C. | 0 | 16 | 0 | 16 | 1 | 16 |
|
| Hypotension | Vascular disorders | Non-systematic Assessment | After the third blood draw the patient became lightheaded, the blood pressure was 86/50. |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |