Trial Outcomes & Findings for Heat Therapy to Reduce Pain and Improve Walking Tolerance (NCT NCT03435835)
NCT ID: NCT03435835
Last Updated: 2022-08-30
Results Overview
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).
COMPLETED
NA
19 participants
Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 min
2022-08-30
Participant Flow
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.
Nineteen participants were consented, but three were withdrawn before receiving an experimental treatment due to the inability to safely and consistently perform the treadmill exercise test.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.
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
8
|
|
First Intervention
COMPLETED
|
8
|
8
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
8
|
8
|
|
Washout
COMPLETED
|
8
|
8
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
8
|
|
Second Intervention
COMPLETED
|
8
|
8
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heat Therapy to Reduce Pain and Improve Walking Tolerance
Baseline characteristics by cohort
| Measure |
All Study Participants
n=16 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.
|
|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Immediately after exposure to a single session of heat therapy or sham treatment, up to ~20 minExercise 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).
Outcome measures
| Measure |
Sham Treatment
n=16 Participants
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).
|
Heat Therapy
n=16 Participants
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.
|
|---|---|---|
|
Peak Walking Time
|
955.6 seconds
Standard Deviation 84.3
|
947.7 seconds
Standard Deviation 88.1
|
SECONDARY outcome
Timeframe: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 minExercise 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).
Outcome measures
| Measure |
Sham Treatment
n=16 Participants
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).
|
Heat Therapy
n=16 Participants
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.
|
|---|---|---|
|
Claudication Onset Time
|
452.6 Seconds
Standard Deviation 53.2
|
442.9 Seconds
Standard Deviation 65.1
|
SECONDARY outcome
Timeframe: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 minBlood pressure was measured in the left arm using a stethoscope and sphygmomanometer during exercise.
Outcome measures
| Measure |
Sham Treatment
n=16 Participants
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).
|
Heat Therapy
n=16 Participants
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.
|
|---|---|---|
|
Peak Systolic Blood Pressure
|
193.3 mmHg
Standard Deviation 23.2
|
189.3 mmHg
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 minBlood pressure was measured in the left arm using a stethoscope and sphygmomanometer prior and during exercise
Outcome measures
| Measure |
Sham Treatment
n=16 Participants
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).
|
Heat Therapy
n=16 Participants
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.
|
|---|---|---|
|
Peak Diastolic Blood Pressure
|
74.2 mmHg
Standard Deviation 9.7
|
73.5 mmHg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: The exercise test was performed immediately after exposure to a single session of either heat therapy or sham, up to ~20 minThe tissue saturation index (TSI%) of the most symptomatic leg was assessed with a commercially available NIRS system (Portamon, Artinis Medical Systems, The Netherlands).
Outcome measures
| Measure |
Sham Treatment
n=14 Participants
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).
|
Heat Therapy
n=14 Participants
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.
|
|---|---|---|
|
Peak Calf Tissue Saturation Index
|
43.9 % tissue saturation
Standard Deviation 7.6
|
43.1 % tissue saturation
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 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-1Commercially 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)
Outcome measures
| Measure |
Sham Treatment
n=14 Participants
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).
|
Heat Therapy
n=14 Participants
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.
|
|---|---|---|
|
Post-exercise Plasma Endothelin-1 Concentration
|
2.0 pg/mL
Standard Deviation 0.6
|
1.7 pg/mL
Standard Deviation 0.5
|
Adverse Events
Sham Treatment
Heat Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Treatment
n=16 participants at risk
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).
|
Heat Therapy
n=16 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • Throughout the duration of the study (approximately 1 month).
|
0.00%
0/16 • Throughout the duration of the study (approximately 1 month).
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • Throughout the duration of the study (approximately 1 month).
|
6.2%
1/16 • Throughout the duration of the study (approximately 1 month).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place