Heat & Aerobic Training (HEAT) Study



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - 64
Updated:4/21/2016
Start Date:August 2015
End Date:June 2017
Contact:Tiffany Bullard, BS
Email:bullard3@illinois.edu
Phone:217-300-7484

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Heat & Aerobic Training (HEAT) for Pre-Hypertensive Middle-Aged Adults

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 your convenience), and 2 pre- and 2-post-testing sessions.

Exercise has been associated with enhanced cognitive functioning. Several physiological
mechanisms of change have been proposed, including increased blood-flow, vascular
functioning, and neurological changes. Similar outcomes are also associated with
partial-body and full-body heat therapy (e.g. steam-room or dry-sauna). The purpose of this
study is to compare full-body HEAT treatments combined with exercise in a 14-week program to
an exercise-only condition. The exercise program will involve moderate-intensity aerobic
exercise training. All participants will also be asked to adhere to the American Heart
Association's guidelines for reducing and controlling 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 for a body mass index between 18 and 25).

It is hypothesized that heat treatments combined with exercise will enhance the body's
adaptive responses to exercise which in turn, should reduce blood pressure & blood flow, and
improve cognitive functioning and related psychosocial outcomes (including anxiety and
mindfulness). A two-armed (parallel groups design) randomized controlled trial involving
heat and aerobic training (HEAT) will be compared with an exercise only (ExOnly) control
condition. Therefore, the HEAT groups will receive 42 exercise classes each followed by a
heat treatment involving 11-20 minutes of steam-room therapy. Post-exercise time will be
matched in the control condition by having participants sit in the lobby after each session.
The exercise interventions and assessments will be conducted by trained exercise staff. The
participants will be assessed at baseline and post-intervention. Additionally, brief
assessments will be administered at each session (pre and post) and logs will be
administered to participants on a weekly basis. Assessments will include (a) physical
activity & biometric monitoring, (b) performance on neurocognitive tests, (c) endothelial
function, (d) a battery of psychosocial questionnaires, and (e) functional performance
measures.

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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)
We found this trial at
1
site
Urbana, Illinois 61801
Principal Investigator: Sean P Mullen, PhD
Phone: 217-300-7484
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mi
from
Urbana, IL
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