Overweight and ObesityNCT03904810
Low-frequency High-Intensity Interval Training in Overweight or Obese Young Adults
A study testing Exercise intervention in people with Overweight and Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: The relationship between the frequency of high-intensity interval training (HIIT) and the resultant adaptations is largely unclear. Purpose: This study examined the effects of different frequencies of HIIT compared to moderate-intensity continuous training (MICT) on body composition and cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2016to 31 Aug 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 18 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese male
- Aged 18-30 years
- Overweight or obesity, defined as BMI ≥23 kg/m2 (classification of overweight for Hong Kong adults according to Department of Health, Hong Kong SAR Government)
Who cannot join
- Chronic medical and health condition such as cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases
- Hypertension (blood pressure >140/90 mmHg)
- Contraindications to participating in physical exercise
- Any pre-existing medical or physical issues that affected the experimental test
- Physically active (i.e., >3 hours of moderate-intensity exercise weekly)
- Lean overweight population (BMI ≥23 kg/m2, but percent body fat ≤20%) according to the BMI data corresponding to bioelectrical impedance estimated percent body fat cut-off value among Hong Kong Chinese adults.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Low-frequency High-Intensity Interval Training (HIIT) in Overweight or Obese Young Adults
Background: The relationship between the frequency of high-intensity interval training (HIIT) and the resultant adaptations is largely unclear. Purpose: This study examined the effects of different frequencies of HIIT compared to moderate-intensity continuous training (MICT) on body composition and cardiovascular biomarkers in overweight or obese adults. Methods: This study was a randomized, controlled, single-blinded trial. Fifty-six overweight or obese men aged between 18 and 30 years were randomly assigned to no-intervention control (CON; n=14), MICT performed thrice weekly (MICT×3/wk; n=9), HIIT performed thrice weekly (HIIT×3/wk; n=14), HIIT performed twice weekly (HIIT×2/wk; n=10), and HIIT performed once weekly (HIIT×1/wk; n=9). Each HIIT session consisted of 12 × 1-min bouts at 90% heart rate reserve (HRR), interspersed with 11 × 1-min bouts at 70% HRR (HIIT×3/wk: 69 min/wk; HIIT×2/wk: 46 min/wk; HIIT×1/wk: 23 min/wk). Aerobic capacity, resting heart rate, body composition, waist circumference, blood pressure, endothelial function, fasting blood glucose and lipids, circulatory adipokines and inflammatory biomarkers were examined at baseline, after 4 weeks and 8 weeks of intervention.
Read the detailed description
Individuals who fulfilled the following inclusion criteria were invited to participate in the present study: 1) Chinese male; 2) aged 18-30 years; and 3) overweight or obesity, defined as BMI ≥23 kg/m2 (classification of overweight for Hong Kong adults according to Department of Health, Hong Kong SAR Government) (13). Subjects were excluded if they had: 1) chronic medical and health condition such as cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases; 2) hypertension (blood pressure >140/90 mmHg); 3) contraindications to participating in physical exercise; 4) any pre-existing medical or physical issues that affected the experimental test; 5) physically active (i.e., >3 hours of moderate-intensity exercise weekly) or 6) lean overweight population (BMI ≥23 kg/m2, but percent body fat ≤20%) according to the BMI data corresponding to bioelectrical impedance estimated percent body fat cut-off value among Hong Kong Chinese adults.
Of those who were screened, 103 Chinese young adults were eligible to participate in this study. They were provided with written and verbal information on the study protocol and the possible associated discomforts and risks followed by obtaining their written informed consent to participate in this study. The study protocol and consent form were approved by the Human Subjects Ethics Sub-Committee of The Hong Kong Polytechnic University (ethics approval reference number: HSEARS20160927005-01).
This study was a single-blind, randomized, controlled trial. Subjects were randomly assigned to 1) no-intervention control (CON), 2) MICT performed thrice weekly (MICTx3/wk), 3) HIIT performed thrice weekly (HIITx3/wk), 4) twice weekly (HIITx2/wk), and 5) once weekly (HIITx1/wk). All subjects were instructed to maintain their usual daily activities. Outcome measures including aerobic capacity, body composition, blood pressure, resting heart rate, endothelial function, arterial stiffness, fasting glucose, lipids markers, adipokine marker, and inflammatory marker were assessed at baseline, 4 weeks and 8 weeks after the intervention.
- Conditions
- Overweight and Obesity
- Being tested
- Exercise intervention
- Keywords
- HIIT, Exercise frequency, Exercise intensity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
HIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface. All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down. Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR]. For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR. All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in this group do not received any intervention |
| Moderate Intensity Continuous Training ×3/wk | Active comparator | Subjects in this group will receive three sessions of Moderate-Intensity Continuous Training per week throughout the 8 weeks experimental period Receives: Behavioral: Exercise intervention |
| High Intensity Interval Training×3/wk | Active comparator | Subjects in this group will receive three sessions of High-Intensity Interval Training per week throughout the 8 weeks experimental period Receives: Behavioral: Exercise intervention |
| High Intensity Interval Training×2/wk | Active comparator | Subjects in this group will receive two session of High-Intensity Interval Training per week throughout the 8 weeks experimental period Receives: Behavioral: Exercise intervention |
| High Intensity Interval Training×1/wk | Active comparator | Subjects in this group will receive one session of High-Intensity Interval Training per week throughout the 8 weeks experimental period Receives: Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated maximal oxygen consumption
Estimated maximal oxygen consumption achieved during the 20-meter shuttle multistage run test were used for the assessment of aerobic fitness Unit: body weight, estimated oxygen consumption and minute will be combined to report the estimated VO2max in ml/kg/min.
Measured: 8 weeks
Total running distance
Total running distance in meters achieved during the 20-meter shuttle multistage run test were used for the assessment of aerobic fitness
Measured: 8 weeks
Total body fat percentage
Total body fat percentage were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Measured: 8 weeks
Total body fat mass
Total body fat mass in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Measured: 8 weeks
Total body fat-free mass percentage
Total body fat-free mass percentage were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Measured: 8 weeks
Total fat-free mass
Total body fat-free mass were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Measured: 8 weeks
Trunk fat mass
Trunk fat mass in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Measured: 8 weeks
Body weight
Body weight in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Measured: 8 weeks
Body height
Body height in meter were assessed.
Measured: 8 weeks
Body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2
Measured: 8 weeks
Waist circumference
Waist circumference was determined to the nearest 0.1 cm of a contact tension tape. The tape was applied directly to the skin at the mid-point between the lower margin of the last palpable rib and the top of the iliac crest.
Measured: 8 weeks
Secondary outcomes (16)
Systolic blood pressure
Systolic blood pressure was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
Measured: 8 weeks
Diastolic blood pressure
Diastolic blood pressure was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
Measured: 8 weeks
Mean arterial pressure
Mean arterial pressure was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
Measured: 8 weeks
Resting heart rate
Resting heart rate was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
Measured: 8 weeks
Endothelial function
Endothelial function were measured by digital plethysmography using EndoPAT 2000 device (ITAMAR Medical, Caesarea, Israel) and expressed as natural log reactive hyperemia index (LnRHI)
Measured: 8 weeks
Arterial stiffness
Arterial stiffness were measured by digital plethysmography using EndoPAT 2000 device (ITAMAR Medical, Caesarea, Israel) and expressed as augmentation index normalized to heart rate of 75 bpm (AI@75)
Measured: 8 weeks
Serum fasting glucose
Fresh blood samples were sent to an accredited medical laboratory to measure the serum fasting glucose concentrations by commercial test kit methods with an automatic clinical chemistry analyzer (Architect CI8200, Abbott Diagnostics, USA)
Measured: 8 weeks
Triglycerides
Fresh blood samples were sent to an accredited medical laboratory to measure the serum triglycerides concentrations by commercial test kit methods with an automatic clinical chemistry analyzer (Architect CI8200, Abbott Diagnostics, USA)
Measured: 8 weeks
High-density lipoproteins (HDL) cholesterol
Fresh blood samples were sent to an accredited medical laboratory to measure the serum high-density lipoproteins-cholesterol (HDL-C) concentrations by commercial test kit methods with an automatic clinical chemistry analyzer (Architect CI8200, Abbott Diagnostics, USA)
Measured: 8 weeks
Low-density lipoprotein (LDL) cholesterol
Low-density lipoprotein (LDL) cholesterol in serum was measured by an automatic chemistry analyzer (AU-480, Beckman Coulter, USA)
Measured: 8 weeks
Interleukin 6
Commercially available enzyme-linked immunosorbent assay kits (R\&D systems, Minneapolis, MN) were used to determine interleukin 6
Measured: 8 weeks
Tumor necrosis factor alpha
Commercially available enzyme-linked immunosorbent assay kits (R\&D systems, Minneapolis, MN) were used to determine tumor necrosis factor alpha
Measured: 8 weeks
C-reactive protein
Commercially available enzyme-linked immunosorbent assay kits (R\&D systems, Minneapolis, MN) were used to determine c-reactive protein
Measured: 8 weeks
Adiponectin
Commercially available enzyme-linked immunosorbent assay kits (R\&D systems, Minneapolis, MN) were used to determine adiponectin
Measured: 8 weeks
Intercellular adhesion molecule-1
Commercially available enzyme-linked immunosorbent assay kits (R\&D systems, Minneapolis, MN) were used to determine intercellular adhesion molecule-1
Measured: 8 weeks
Vascular cell adhesion molecule-1
Commercially available enzyme-linked immunosorbent assay kits (R\&D systems, Minneapolis, MN) were used to determine vascular cell adhesion molecule-1
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Oct 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Model description
- 5 groups ×3 times factorial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parco M. Siu, PhD, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904810
- Sponsor's protocol ID
- HIIT001
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low-frequency High-Intensity Interval Training (HIIT) in Overweight or Obese Young Adults
- ClinicalTrials.gov ID
- NCT03904810
- Acronym / sponsor ID
- HIIT001
- Conditions
- Overweight and Obesity
- Keywords
- HIIT, Exercise frequency, Exercise intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 5 Apr 2019 (actual)
- 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.
Background: The relationship between the frequency of high-intensity interval training (HIIT) and the resultant adaptations is largely unclear. Purpose: This study examined the effects of different frequencies of HIIT compared to moderate-intensity continuous training (MICT) on body composition and cardiovascular biomarkers in overweight or obese adults. Methods: This study was a randomized, controlled, single-blinded trial. Fifty-six overweight or obese men aged between 18 and 30 years were randomly assigned to no-intervention control (CON; n=14), MICT performed thrice weekly (MICT×3/wk; n=9), HIIT performed thrice weekly (HIIT×3/wk; n=14), HIIT performed twice weekly (HIIT×2/wk; n=10), and HIIT performed once weekly (HIIT×1/wk; n=9). Each HIIT session consisted of 12 × 1-min bouts at 90% heart rate reserve (HRR), interspersed with 11 × 1-min bouts at 70% HRR (HIIT×3/wk: 69 min/wk; HIIT×2/wk: 46 min/wk; HIIT×1/wk: 23 min/wk). Aerobic capacity, resting heart rate, body composition, waist circumference, blood pressure, endothelial function, fasting blood glucose and lipids, circulatory adipokines and inflammatory biomarkers were examined at baseline, after 4 weeks and 8 weeks of intervention.
Detailed description
Individuals who fulfilled the following inclusion criteria were invited to participate in the present study: 1) Chinese male; 2) aged 18-30 years; and 3) overweight or obesity, defined as BMI ≥23 kg/m2 (classification of overweight for Hong Kong adults according to Department of Health, Hong Kong SAR Government) (13). Subjects were excluded if they had: 1) chronic medical and health condition such as cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases; 2) hypertension (blood pressure >140/90 mmHg); 3) contraindications to participating in physical exercise; 4) any pre-existing medical or physical issues that affected the experimental test; 5) physically active (i.e., >3 hours of moderate-intensity exercise weekly) or 6) lean overweight population (BMI ≥23 kg/m2, but percent body fat ≤20%) according to the BMI data corresponding to bioelectrical impedance estimated percent body fat cut-off value among Hong Kong Chinese adults.
Of those who were screened, 103 Chinese young adults were eligible to participate in this study. They were provided with written and verbal information on the study protocol and the possible associated discomforts and risks followed by obtaining their written informed consent to participate in this study. The study protocol and consent form were approved by the Human Subjects Ethics Sub-Committee of The Hong Kong Polytechnic University (ethics approval reference number: HSEARS20160927005-01).
This study was a single-blind, randomized, controlled trial. Subjects were randomly assigned to 1) no-intervention control (CON), 2) MICT performed thrice weekly (MICTx3/wk), 3) HIIT performed thrice weekly (HIITx3/wk), 4) twice weekly (HIITx2/wk), and 5) once weekly (HIITx1/wk). All subjects were instructed to maintain their usual daily activities. Outcome measures including aerobic capacity, body composition, blood pressure, resting heart rate, endothelial function, arterial stiffness, fasting glucose, lipids markers, adipokine marker, and inflammatory marker were assessed at baseline, 4 weeks and 8 weeks after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- 5 groups ×3 times factorial design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in this group do not received any intervention |
| Moderate Intensity Continuous Training ×3/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive three sessions of Moderate-Intensity Continuous Training per week throughout the 8 weeks experimental period |
| High Intensity Interval Training×3/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive three sessions of High-Intensity Interval Training per week throughout the 8 weeks experimental period |
| High Intensity Interval Training×2/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive two session of High-Intensity Interval Training per week throughout the 8 weeks experimental period |
| High Intensity Interval Training×1/wk | Active comparator | Behavioral: Exercise interventionSubjects in this group will receive one session of High-Intensity Interval Training per week throughout the 8 weeks experimental period |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese male
- Aged 18-30 years
- Overweight or obesity, defined as BMI ≥23 kg/m2 (classification of overweight for Hong Kong adults according to Department of Health, Hong Kong SAR Government)
Key exclusion criteria (6 listed)
- Chronic medical and health condition such as cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases
- Hypertension (blood pressure >140/90 mmHg)
- Contraindications to participating in physical exercise
- Any pre-existing medical or physical issues that affected the experimental test
- Physically active (i.e., >3 hours of moderate-intensity exercise weekly)
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 |
|---|---|---|
| Exercise interventionHIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface. All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down. Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR]. For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR. All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach. | Behavioural | High Intensity Interval Training×1/wk, High Intensity Interval Training×2/wk, High Intensity Interval Training×3/wk, Moderate Intensity Continuous Training ×3/wk |
Primary outcome
Estimated maximal oxygen consumption
Time frame: 8 weeks
Estimated maximal oxygen consumption achieved during the 20-meter shuttle multistage run test were used for the assessment of aerobic fitness Unit: body weight, estimated oxygen consumption and minute will be combined to report the estimated VO2max in ml/kg/min.
Total running distance
Time frame: 8 weeks
Total running distance in meters achieved during the 20-meter shuttle multistage run test were used for the assessment of aerobic fitness
Total body fat percentage
Time frame: 8 weeks
Total body fat percentage were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Total body fat mass
Time frame: 8 weeks
Total body fat mass in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Total body fat-free mass percentage
Time frame: 8 weeks
Total body fat-free mass percentage were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Total fat-free mass
Time frame: 8 weeks
Total body fat-free mass were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Trunk fat mass
Time frame: 8 weeks
Trunk fat mass in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Body weight
Time frame: 8 weeks
Body weight in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
Body height
Time frame: 8 weeks
Body height in meter were assessed.
Body mass index (BMI)
Time frame: 8 weeks
Weight and height will be combined to report BMI in kg/m^2
Waist circumference
Time frame: 8 weeks
Waist circumference was determined to the nearest 0.1 cm of a contact tension tape. The tape was applied directly to the skin at the mid-point between the lower margin of the last palpable rib and the top of the iliac crest.
16 secondary outcomes
Systolic blood pressure
Time frame: 8 weeks
Diastolic blood pressure
Time frame: 8 weeks
Mean arterial pressure
Time frame: 8 weeks
Resting heart rate
Time frame: 8 weeks
Endothelial function
Time frame: 8 weeks
Arterial stiffness
Time frame: 8 weeks
Serum fasting glucose
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
High-density lipoproteins (HDL) cholesterol
Time frame: 8 weeks
Low-density lipoprotein (LDL) cholesterol
Time frame: 8 weeks
Interleukin 6
Time frame: 8 weeks
Tumor necrosis factor alpha
Time frame: 8 weeks
C-reactive protein
Time frame: 8 weeks
Adiponectin
Time frame: 8 weeks
Intercellular adhesion molecule-1
Time frame: 8 weeks
Vascular cell adhesion molecule-1
Time frame: 8 weeks
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 5 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Overweight and Obesity, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 6 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 5 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 Hong Kong. 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?
Estimated maximal oxygen consumption (time frame: 8 weeks). The study lists 11 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 5 Apr 2019.