Trial Outcomes & Findings for Home-based Leg Heat Therapy (NCT NCT03763331)

NCT ID: NCT03763331

Last Updated: 2023-03-01

Results Overview

Change in 6-min walk distance from baseline to the 8-week follow-up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2023-03-01

Participant Flow

Participants were recruited by referral from the peripheral vascular disease clinic at the Department of Vascular Surgery at Indiana University's Methodist Hospital, the Non-Invasive Vascular Laboratory at Methodist Hospital, and direct participant contact by the Indiana CTSI Research Network (ResNet) office. The first participant was randomized on January 14, 2019. Final follow-up occurred on June 21, 2021.

A total of 542 patients were referred and screened for the study. Four hundred and twenty-eight participants were deemed ineligible and 80 refused to participate. The remaining 34 patients were randomly allocated to receive HT (n = 18) or the control treatment (n = 16).

Participant milestones

Measure	Sham Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Overall Study STARTED	16	18
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Sham Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Non-compliance	0	3

Baseline Characteristics

Home-based Leg Heat Therapy

Baseline characteristics by cohort

Measure	Sham n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Total n=30 Participants Total of all reporting groups
Age, Continuous	68.9 years STANDARD_DEVIATION 5.79 • n=5 Participants	62.9 years STANDARD_DEVIATION 8.9 • n=7 Participants	65.9 years STANDARD_DEVIATION 7.99 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Change in 6-min walk distance from baseline to the 8-week follow-up

Outcome measures

Measure	Sham n=14 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Change in 6-min Walk Distance	-0.9 meters Interval -5.8 to 14.3	21.3 meters Interval 10.1 to 42.4

SECONDARY outcome

Timeframe: 8 weeks

Change in treadmill peak walking time from baseline to 8-week follow-up

Outcome measures

Measure	Sham n=14 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Change in Treadmill Peak Walking Time	61.5 seconds Standard Deviation 111.2	109.5 seconds Standard Deviation 85.4

SECONDARY outcome

Timeframe: 8 weeks

Change in peak calf blood flow during reactive hyperemia from baseline to the 8-week follow-up

Outcome measures

Measure	Sham n=11 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=11 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Change in Peak Calf Blood Flow	-4.8 mL/min/100 g Standard Deviation 21.9	-2.8 mL/min/100 g Standard Deviation 11

SECONDARY outcome

Timeframe: 8 weeks

Change in cutaneous vascular conductance from baseline to the 8-week follow-up

Outcome measures

Measure	Sham n=14 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Change in Leg Cutaneous Vascular Conductance	-2.6 percentage of maximal cutaneous vascular Standard Deviation 13.9	-0.7 percentage of maximal cutaneous vascular Standard Deviation 16.3

SECONDARY outcome

Timeframe: 8 weeks

Change in Vascular Quality of Life Questionnaire-6 score from baseline to the 8-week follow-up. The total VASCUQOL score is the average score of questions answered and ranges from 1 (worst QOL) to 7 (best QOL)

Outcome measures

Measure	Sham n=14 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Change in the Vascular Quality of Life Questionnaire-6 Score	0.6 score on a scale Standard Deviation 0.8	0.5 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 8 weeks

Change in the physical functioning subscale score from baseline to the 8-week follow-up. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. A high score defines a more favorable health state.

Outcome measures

Measure	Sham n=14 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=15 Participants Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Change in the Short Form 36 Physical Functioning Score	4.5 score on a scale Standard Deviation 10.8	4.5 score on a scale Standard Deviation 15.9

Adverse Events

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heat Therapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sham n=16 participants at risk Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 33 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.	Heat Therapy n=18 participants at risk Participants will be dressed in water-circulating trousers that are connected to a pump. Water at 43 degrees Celsius will be circulated through the pants for 90 minutes daily for 8 weeks.
Cardiac disorders Supraventricular tachycardia at the onset of treadmill test	0.00% 0/16 • Throughout the duration of the study (i.e. approximately 12 weeks).	5.6% 1/18 • Number of events 1 • Throughout the duration of the study (i.e. approximately 12 weeks).
Musculoskeletal and connective tissue disorders Fall during the 6-min walk test	0.00% 0/16 • Throughout the duration of the study (i.e. approximately 12 weeks).	5.6% 1/18 • Number of events 1 • Throughout the duration of the study (i.e. approximately 12 weeks).
Musculoskeletal and connective tissue disorders Knee injury	0.00% 0/16 • Throughout the duration of the study (i.e. approximately 12 weeks).	5.6% 1/18 • Number of events 1 • Throughout the duration of the study (i.e. approximately 12 weeks).
Skin and subcutaneous tissue disorders Transient mild leg skin irritation	0.00% 0/16 • Throughout the duration of the study (i.e. approximately 12 weeks).	5.6% 1/18 • Number of events 1 • Throughout the duration of the study (i.e. approximately 12 weeks).

Additional Information

Dr. Bruno Roseguini

Purdue University

Phone: 7654906284

Email: brosegui@purdue.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place