Pre-hypertensionHEATNCT02546726
Heat & Aerobic Training (HEAT) Study
A study testing Heat & Aerobic Training (HEAT) and Exercise Only in people with Pre-hypertension, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Pre-hypertension
- What is being tested?
- Heat & Aerobic Training (HEAT) and Exercise Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2015to 24 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Louise Freer Hall, Exercise Technology & Cognition Laboratory, Rm 253
Urbana, Illinois, 61801
About this study
Official title: 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 study participants' convenience), and 2 pre- and 2-post-testing sessions.
Read the 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
- Being tested
- Heat & Aerobic Training (HEAT), Exercise Only
- Keywords
- heat therapy, steam-room, aerobic exercise, hypertension, multiple behavior change, lifestyle modification
- Medical subject headings
- Prehypertension, Hyperthermia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat & Aerobic Training (HEAT)Behavioural
Also called STEAM
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 OnlyBehavioural
Also called ExOnly
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.
| Study group | Role | What they receive |
|---|---|---|
| Heat & Aerobic Training (HEAT) Condition | Experimental | 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. Receives: Behavioral: Heat & Aerobic Training (HEAT) |
| Exercise Only | Active comparator | 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. Receives: Behavioral: Exercise Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14-week change
Secondary outcomes (11)
anxiety
Perceptions of anxiety will be measured by the Hospital Anxiety and Depression Scale (HADS). Items for each subscale (anxiety and depression) will be summed (un-weighted) and averaged.
Measured: 14-week change, intra-session change
mindfulness
The 15-item Mindfulness and Attention Scale (MAAS) will be used to assess mindfulness. A composite score will be computed based on an average of the unweighted sum of items.
Measured: 14-week change
stress
Perceived stress will be assessed with the 10-item Perceived Stress Scale. A composite score will be calculated based on an unweighted sum and average of the items.
Measured: 14-week change, intra-session change
quality of life
Quality of life will be measured by the 5-item Satisfaction with Life Scale. Items will be summed and averaged.
Measured: 14-week change
perceptions of memory
Assessed by the 50-item Memory Self-Efficacy Questionnaire and the 12-item Memory Controllability Inventory. Items for each scale and subscale will be summed (un-weighted) and averaged. Scale composites will be used individually.
Measured: 14-week change
processing speed
A linear combination (composite score based on an un-weighted sum) based on performance on the Digit Symbol Coding Task, Letter Comparison and Pattern Comparison will be used as an index of cognitive processing speed.
Measured: 14-week change
inhibition/attentional control
A linear combination based on performance on standard Stroop and Flanker paradigms will be used as an index of inhibitory control. Established "cognitive cost" algorithms will be used incorporating only the difference in reaction times as one progresses to the most challenging trials. Scores will be weighed evenly across tests when calculating the composite index of inhibition/attentional control.
Measured: 14-week change
memory
A linear combination based on performance on the N-back and Sternberg Task (working memory) as well as Logical Memory Test, Free Recall and Paired Associates (episodic memory) will be used as an overall index of memory ability. Reaction times will be weighed evenly across tests when calculating the composite measure. Only the most challenging trials of N-Back (2-back) will be used to compute an average reaction time score.
Measured: 14-week change
visual spatial skills
A linear combination based on performance on the Card Rotations Test, Hidden Patterns Test, Spatial Relations, Paper Folding, and Form Boards will be used as an index of visio-spatial skills. Reaction times will be weighed evenly across tests when calculating the composite measure.
Measured: 14-week change
multi-tasking
A linear combination based on performance on a Dual Task and Task-Switching paradigm will be used as an index of multi-tasking ability. The algorithm will use established measures involving cost in reaction times. Performance on both tests will be evenly weighted.
Measured: 14-week change
global executive functioning
An iPad-version of the established Trail-Making (A\&B) Test will be used to assess general executive functioning overall. The iPad version involves trials with stationary and moving stimuli within the A (alpha-only) and B (alpha-numeric) condition. A modified algorithm based on the commonly used index of global executive function (subtracting B - A) will be implemented for data analysis. Specifically, the outcome measure will be calculated as:
Trails AB reaction time (RT) cost = ((Average RT for hard/moving B trials) - (Average RT for easy/stationary B trials)) - ((Average RT for hard/moving A - Average RT for easy/stationary A trials)).
Measured: 14-week change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start21 Aug 2015
- Primary completion24 May 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mullen, University of Illinois at Urbana-Champaign
- Investigators
- Sean P Mullen, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546726
- Sponsor's protocol ID
- RB15229
- Other IDs
- 15935
- Acronym
- HEAT
- Status last verified
- Apr 2019
- First submitted
- 18 Aug 2015
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat & Aerobic Training (HEAT) for Pre-Hypertensive Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT02546726
- Acronym / sponsor ID
- HEAT / RB15229
- Conditions
- Pre-hypertension
- Keywords
- heat therapy, steam-room, aerobic exercise, hypertension, multiple behavior change, lifestyle modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 21 Aug 2015 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat & Aerobic Training (HEAT) Condition | Experimental | Behavioral: Heat & Aerobic Training (HEAT)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. |
| Exercise Only | Active comparator | Behavioral: Exercise OnlyParticipants 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. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat & Aerobic Training (HEAT)Also: STEAMParticipants 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. | Behavioural | Heat & Aerobic Training (HEAT) Condition |
| Exercise OnlyAlso: ExOnlyParticipants 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. | Behavioural | Exercise Only |
Primary outcome
blood flow
Time frame: 14-week change
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.
blood pressure
Time frame: 14-week change
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.
11 secondary outcomes
anxiety
Time frame: 14-week change, intra-session change
mindfulness
Time frame: 14-week change
stress
Time frame: 14-week change, intra-session change
quality of life
Time frame: 14-week change
perceptions of memory
Time frame: 14-week change
processing speed
Time frame: 14-week change
inhibition/attentional control
Time frame: 14-week change
memory
Time frame: 14-week change
visual spatial skills
Time frame: 14-week change
multi-tasking
Time frame: 14-week change
global executive functioning
Time frame: 14-week change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Study Contact FormLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P Mullen, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat & Aerobic Training (HEAT) and Exercise Only in people with Pre-hypertension, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood flow (time frame: 14-week change). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.