Clinical trial NCT02546726: Heat & Aerobic Training (HEAT) Study
Official title: Heat & Aerobic Training (HEAT) for Pre-Hypertensive Middle-Aged Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-hypertension
Keywords: heat therapy
steam-room
aerobic exercise
hypertension
multiple behavior change
lifestyle modification
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 41
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: blood flow
timeFrame: 14-week change
measure: blood pressure
timeFrame: 14-week change
Secondary outcomes:
measure: anxiety
timeFrame: 14-week change, intra-session change
measure: mindfulness
timeFrame: 14-week change
measure: stress
timeFrame: 14-week change, intra-session change
measure: quality of life
timeFrame: 14-week change
measure: perceptions of memory
timeFrame: 14-week change
measure: processing speed
timeFrame: 14-week change
measure: inhibition/attentional control
timeFrame: 14-week change
measure: memory
timeFrame: 14-week change
measure: visual spatial skills
timeFrame: 14-week change
measure: multi-tasking
timeFrame: 14-week change
measure: global executive functioning
timeFrame: 14-week change
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Louise Freer Hall, Exercise Technology & Cognition Laboratory, Rm 253
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
References: