Heat & Aerobic Training (HEAT) Study

NCT ID: NCT02546726

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-21
• Study Completion Date: 2017-05-24

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.

Detailed Description

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.

Conditions

Pre-hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Heat & Aerobic Training (HEAT) Condition

Participants 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.

Group Type: EXPERIMENTAL

Heat & Aerobic Training (HEAT)

Intervention Type: BEHAVIORAL

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.

Exercise Only

Participants 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.

Group Type: ACTIVE_COMPARATOR

Exercise Only

Intervention Type: BEHAVIORAL

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.

Interventions

Heat & Aerobic Training (HEAT)

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.

Intervention Type: BEHAVIORAL

Exercise Only

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

STEAM; ExOnly

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Sean Mullen

Associate Professor of Kinesiology & Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean P Mullen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

Louise Freer Hall, Exercise Technology & Cognition Laboratory, Rm 253

Urbana, Illinois, United States

Countries

United States

Related Links

http://exercisestudy.com/steam

Study Contact Form

Other Identifiers

15935

Identifier Type: OTHER

Identifier Source: secondary_id

RB15229

Identifier Type: -

Identifier Source: org_study_id