Heat & Aerobic Training (HEAT) Study
HEAT
2 other identifiers
interventional
41
1 country
1
Brief Summary
This study is intended for inactive, middle-aged adults with untreated pre-hypertension who live in the Urbana-Champaign area, who are interested in a comprehensive program designed to enhance physical activity \& reduce blood pressure. All participants will be asked to engage in a program developed in accordance with American Heart Association's recommendations. Specifically, the program will encourage and support lifestyle behavior changes such as quitting smoking, eating heart-healthy food, and reducing excessive alcohol, in addition to weekly exercise. The exercise program will involve a 14-week aerobic training program (3 weekly sessions, scheduled at study participants' convenience), and 2 pre- and 2-post-testing sessions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2015
CompletedStudy Start
First participant enrolled
August 21, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2017
CompletedApril 17, 2019
April 1, 2019
1.8 years
August 18, 2015
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
blood flow
Participants will be asked to fast for 6 hours and avoid alcohol \& caffeine for 24 hours. They will arrive in a postprandial state and blood flow will be assessed on the calf using strain-gauge plethysmography. Data will be presented as peak hyperemic calf blood flow (CBF) and total CBF. Total CBF will be calculated as area under the curve of the 3-min hyperemic CBF response, based on 13 measures (post-occlusion) using the trapezoidal integration method (see Heffernan et al 2009). Total CBF is an overall estimate of the dilatory capacity of the vessels and therefore serves as an indirect measure of endothelial function.
14-week change
blood pressure
Resting systolic and diastolic will be assessed on the upper-arm with an automated Omron device that takes 3 continuous measurements and reports the average. After study enrollment, participants will be asked to avoid certain medications, foods and beverages known to alter these measurements. Upon entering the research site, participants will be instructed to sit quietly in a dimly lit room for 10 minutes prior to assessments. Staff will then assess blood pressure in three sequential positions (lying supine, sitting in chair, standing). The 14-week change in blood pressure will be defined as the difference between baseline and program end, using the average measures recorded at each position for systolic, diastolic, and mean arterial pressure.
14-week change
Secondary Outcomes (11)
anxiety
14-week change, intra-session change
mindfulness
14-week change
stress
14-week change, intra-session change
quality of life
14-week change
perceptions of memory
14-week change
- +6 more secondary outcomes
Study Arms (2)
Heat & Aerobic Training (HEAT) Condition
EXPERIMENTALParticipants will receive supervised, moderate intensity (50-75% maximum heart rate) aerobic exercise sessions, 3 times per week for 50 minutes in duration. After the exercise portion of each session, participants assigned to the HEAT condition will be asked to sit quietly on the bench in the steam-room within their same-sex locker room for no more than 20 minutes. They will start at 11 minutes to get acclimated to the mild heat stress, and gradually work up to 20 minutes. A trained research staff member will be stationed outside the room.
Exercise Only
ACTIVE COMPARATORParticipants will receive supervised, moderate intensity (50-75% maximum heart rate) aerobic exercise sessions, 3 times per week for 50 minutes in duration. After the exercise portion of each session, participants assigned to the Exercise Only condition will be asked to sit quietly on the bench in the lobby of the fitness facility, initially for 11 minutes and then gradually working up to 20 minutes.
Interventions
Participants receive 42 supervised 50-minute, moderately intensive (50-75% max HR) aerobic exercise sessions (3 times per week), followed by 11-20 minutes of post-exercise steam-room therapy. Participants are encouraged to exercise on their own (e.g., 1-2 days of aerobic and/or resistance training) but to refrain from unsupervised steam-room sessions or any other form of heat therapy.
Participants receive 42 supervised 50-minute, moderately intensive (50-75% max HR) aerobic exercise sessions (3 times per week), followed by 11-20 minutes of post-exercise sitting in the lobby of the fitness facility. Participants are encouraged to exercise on their own (e.g., 1-2 days of aerobic and/or resistance training) but to refrain from unsupervised steam-room sessions or any other form of heat therapy.
Eligibility Criteria
You may qualify if:
- Age 45 to 64
- Confirmed pre-hypertensive (120-139 mmHG Systolic / 80-89 Diastolic mmHG) blood pressure by our laboratory staff
- Low active (\< 2 days per week for 30+ minutes over the past 3 months)
- Able and willing to try to adhere to American Heart Association guidelines for managing multiple lifestyle factors contributing to high blood pressure including increasing physical activity (at least 50 minutes, 3 times/week as part of our supervised training sessions), stopping smoking altogether, eating healthier (limiting sodium, eating fruit, veggies, low-fat dairy and lean protein, and reducing saturated fat and total fat), drinking less alcohol (1-2 drinks a day max) and achieving and maintaining a healthy bodyweight (striving or a body mass index between 18 and 25).
- Able to commit to the full length of our program without missing more than 2 consecutive weeks
- Capable of performing moderately intensive aerobic exercise
- Willing to be randomized to one of two groups
- Able to commute to and from fitness facility and UIUC campus
- Own smartphone and have reliable at-home internet access
- Have correctable vision (i.e., at least 20/40 with glasses or contacts with no color blindness)
- Not involved in regular weekly relaxation methods (e.g., yoga, meditation) or heat therapy (e.g., steam-room, sauna, hot baths)
- Not heat sensitive (e.g., have not experienced heat-induced severe rashes, pain, numbness, or tingling; experienced heat-related cramps, illness, or heatstroke; or had surgery requiring general anesthesia that has caused subsequent difficulty regulating body temperature)
- Do not have any type of neuropathy (e.g., peripheral, diabetic)
- Not depressed as indicated by a telephone screening (Abbreviated 5-item Geriatric Depression Scale; GDS-5 score \< 2)
- No cognitive impairment as indicated by a telephone screening (Telephone Interview Cognitive Survey; TICS score \> 21)
You may not qualify if:
- Too young (\< 45) or too old (\> 64)
- Normotensive (\< 120 mmHG Systolic / \< 80 Diastolic mmHG) or hypertensive (\> 140 mmHG Systolic / \> 90 Diastolic mmHG) blood pressure
- Too active (as defined by regularly exercise 2 or more days per week for 30+ minutes over the past 3 months)
- Unable or unwilling to comply with American Heart Association guidelines for managing multiple lifestyle factors contributing to high blood pressure including increasing physical activity (at least 50 minutes, 3 times/week as part of our supervised training sessions), stopping smoking altogether, eating healthier (limiting sodium, eating fruit, veggies, low-fat dairy and lean protein, and reducing saturated fat and total fat), drinking less alcohol (1-2 drinks a day max) and achieving and maintaining a healthy bodyweight (striving or a body mass index between 18 and 25).
- Unable to commit to full length of program
- Incapable of performing moderately intensive aerobic exercise
- Unwilling to be randomized to one of two groups
- Unable to commute to and from fitness facility and UIUC campus
- Does not own smartphone or have reliable at-home internet access
- Does not have correctable vision (i.e., at least 20/40 with glasses or contacts with no color blindness)
- Already involved in regular weekly relaxation methods (e.g., yoga, meditation) or heat therapy (e.g., steam-room, sauna, hot baths)
- Has heat sensitivity (e.g., heat-induced severe rashes, pain, numbness, or tingling; experienced heat-related cramps, illness, or heatstroke; or had surgery requiring general anesthesia that has caused subsequent difficulty regulating body temperature)
- Has any type of neuropathy (e.g., peripheral, diabetic)
- Has depression (as defined by GDS-5 score of 2 or higher)
- Has cognitive impairment (as defined by \< 21 on TICS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Louise Freer Hall, Exercise Technology & Cognition Laboratory, Rm 253
Urbana, Illinois, 61801, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean P Mullen, PhD
University of Illinois at Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Kinesiology & Community Health
Study Record Dates
First Submitted
August 18, 2015
First Posted
September 11, 2015
Study Start
August 21, 2015
Primary Completion
May 24, 2017
Study Completion
May 24, 2017
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share