ObesityNCT02853279
Physical Activity and Intermittent Exercise Training for Cardiovascular and Cognitive Gain in Obese Women
A study testing Interval exercise training and Continuous exercise training (CON) in people with Obesity and Cognitive Ability, General, run by University of Leeds at 2 sites in United Kingdom.
Trial summary
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cognitive Ability, General, Cardiovascular Disease
- What is being tested?
- Interval exercise training and Continuous exercise training (CON)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2011to Jun 2014
- 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 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sedentary women (exercise ≤2 day per week)
- Pre-menopausal (age 35- 50 years)
- BMI of ≥30 kg/m2
- Able to give informed consent .
- Non-smokers
- Vision sufficiently good to complete the cognitive testing (using glasses and/or lenses).
Who cannot join
- Male
- BMI < 30 kg/m2
- Clinically diagnosed with type 1 or type 2 diabetes
- Resting/exercise ECG indicating significant ischemia, recent myocardial infarction or other acute cardiac event or other exercise related ECG abnormalities.
- Unstable angina.
- Uncontrolled hypertension.
Show all 14Show fewer
- Uncontrolled cardiac dysrhythmias
- The use of antidepressant, antianxiety, or thyroid medication.
- Dementia
- Neurological disorder
- Previous stroke or Transient Ischaemic Attack (TIA)
- Musculoskeletal impairment or injury
- Medication that has a direct effect on the brain and is likely to influence cognitive function.
- Current smokers or those who have given up in the previous 6 months
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Sports and Exercise Sciences, University of Leeds
Leeds, West Yorkshire, LS2 9JT
Human Appetite Research Unit
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: The Effect of (i) Physical Activity and (ii) Continuous Versus Intermittent Exercise Training Upon Cardiovascular and Cognitive Function in Obese Women
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Written informed consent will be gained following greater than 48 hours for the purpose of reading the Participant Information sheets. The study will then involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers (i.e. participants who volunteer to exercise train). Participants for stage 1 will then visit the laboratory in the University on three occasions (over a three week period) to be assessed for body composition, exercise tolerance, current physical activity levels, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who have volunteered for the exercise training component (approx 60). These participants will then be randomly divided into two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner at a moderate intensity, whilst the second group will exercise at a heavy intensity but in short bursts. Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
Read the detailed description
The study will involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers. 100 participants for stage 1 will visit the laboratory in the University on three occasions (within a three week period) to be assessed for anthropometric outcomes, body composition, exercise tolerance, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who are happy to continue into the exercise training phase. These participants will then be matched for age and BMI and then randomly (on matched pairs) allocated to one of two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner undertaking continuous exercise, whilst the Group 2 will exercise at a heavy intensity but in short bursts (interval exercise). Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
Recruitment of participants
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Participants will be contacted via email/telephone/letter to provide information regarding this study. All volunteers interested in participating will be contacted to provide general information during a preliminary telephone screening interview. This will be used to check main inclusion and exclusion criteria. The women who fit these criteria will be sent the participant information sheet to read carefully and if still interested invited to attend the first laboratory visit for a screening session. Participants have greater than 48 hours to assess the participant information sheet before they attend this first visit when, if eligible, they will be asked to provide written informed consent.
Laboratory Visits
Visit 1
During this visit the study and all procedures will be explained in detail to all participants, and written informed consent will be taken. A thorough medical history will be obtained and participants will be asked to complete a Recruitment Information Questionnaire (RIQ) to confirm all inclusion/ exclusion criteria. Participants will complete the National Adult Reading Test (NART) which estimates premorbid intelligence levels.
Participants will also complete a Physical Activity Readiness Questionnaire (PAR-Q) which will be reviewed to determine whether participants are fit to continue with the study. Simple measures of body weight, height and waist circumference will be taken. Participants will complete a practice version of the cognitive test battery to demonstrate the tests, ensure participants understand how to perform the tests correctly and assess compliance (effort).
Participants will complete a cycling test on a stationary bicycle under the supervision of the investigator and a medic.
Visit 2
The second visit will involve several measures of arterial health which requires participants to attend in a 12 hour fasted state. Blood vessel function will be assessed using a blood pressure cuff around the lower arm for a period of 5 minutes. Cardiac structure and function will be assessed using two-dimensional (2D) echocardiography. Vascular function will be assessed using ultrasound and applanation tonometry. All procedures are non-invasive. Percentages of body fat and muscle mass will be measured using bioimpedance.
A 60ml blood sample will be taken which will be used to asses endothelial progenitor cell number and function, insulin sensitivity, cholesterol levels and is part of the assessment for health of the arteries and vascular system.
Visit 3
On the third visit a cognitive function test will be completed, which requires participants to attend in a 12 hour fasted state.
Participants will perform a 45 minute battery of cognitive tests. Following the cognitive tests, participants will be asked to complete a cognitive test evaluation questionnaire to assess both subjective and objective cognition.
At the end of the third laboratory visit all participants will be provided with an ActiHeart accelerometer (Actigraph, Pensacola, USA) to wear for a period of one week in order to assess movement counts and sedentary behaviour. At the end of the seven days the accelerometer is given back to or collected by the team and the data downloaded.
The three baseline laboratory visits plus the seven days using the ActiHeart accelerometer all come under stage 1 of the study. Participants will be asked to continue into the exercise training stage (stage 2), and willing volunteers will move through to the second stage of the experiment. All measures will be repeated at 12 weeks (78 hours to 5 days following cessation of the last exercise training session).
- Conditions
- Obesity, Cognitive Ability, General, Cardiovascular Disease
- Being tested
- Interval exercise training, Continuous exercise training (CON)
- Medical subject headings
- Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interval exercise trainingBehavioural
Interval exercise sessions (INT) involving work:recovery ratios of 40 s at 70% delta work-rate followed by 80 s active recovery at 20 W. 70% delta (∆) is 70% of the difference between work rate peak (WRpeak) and work rate at the lactate threshold (WRLT) calculated as:
70%∆ =0.7(〖WR〗_peak- 〖WR〗_LT )+ 〖WR〗_LT
Where WR is work rate, LT is lactate threshold)
Each session was for 30 min and this was undertaken twice per week for 12 weeks. One home based exercise session was incorporated per week.
Continuous exercise training (CON)Behavioural
Exercise sessions involved cycling at 20%∆ work-rate peak for the duration of the session. This work-rate was chosen so that all participants in the group would be exercising in the heavy-intensity domain. To enable participants in the CON exercise group to complete the same amount of work (kJ) as the participants in the INT exercise group, the amount of work that would be completed if the CON participants completed an INT exercise session was calculated. Participants exercised for 26 min (varying to match interval group) twice per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interval exercise training | Experimental | Supervised exercise training undertaking interval exercise twice per week for 30 min each visit over 12 weeks. Receives: Behavioral: Interval exercise training |
| Continuous exercise training | Active comparator | Supervised exercise training undertaking continuous exercise twice per week for 30 min each visit over 12 weeks. Receives: Behavioral: Continuous exercise training (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (CPX)
Maximal oxygen uptake assessed during a ramp incremental cycle ergometry test.
Measured: Change at 12 weeks
Flow mediated dilatation
Percentage change in brachial artery diameter following cuff occlusion using doppler ultrasound.
Measured: Change at 12 weeks
Secondary outcomes (19)
Lactate threshold
Lactate threshold estimated from pulmonary gas exchange criteria
Measured: Baseline and 12 weeks
Blood borne (plasma) inflammatory marker
high sensitivity C reactive protein
Measured: Baseline and 12 weeks
Work rate peak
The peak work rate achieved during the maximal oxygen uptake assessment
Measured: Baseline and 12 weeks
Circulating angiogenic cell number
CD34+CD45dimKDR+ via Flow cytometry
Measured: Baseline and 12 weeks
Circulating cytokines
vascular endothelial growth factor
Measured: Baseline and 12 weeks
Circulating cytokines
stromal derived factor 1
Measured: Baseline and 12 weeks
Arterial stiffness
Doppler assessed and Sphygmacor assessed changes in stiffness via pulse wave velocity
Measured: Baseline and 12 weeks
Cognitive function (Visual spatial learning scale)
Measured: Baseline and 12 weeks
Cognitive function (Tower of Hanoi)
Measured: Baseline and 12 weeks
Cognitive function (Grooved peg board)
Measured: Baseline and 12 weeks
Cognitive function (Visual verbal learning scale)
Measured: Baseline and 12 weeks
Cognitive function (Bakan test))
Measured: Baseline and 12 weeks
Cognitive function (Corsi block tapping)
Measured: Baseline and 12 weeks
Physical activity level
Accelerometer assessed physical activity (Actiheart) worn on the hip
Measured: Baseline and 12 weeks
Blood pressure
Blood pressure
Measured: Baseline and 12 weeks
Body composition
Bioelectrical impedence analysis (BIOSTAT) assessment of fat mass
Measured: Baseline and 12 weeks
Cardiac function (echocardiography)
Measured: Baseline and 12 weeks
Cardiac structure (echocardiography)
Measured: Baseline and 12 weeks
Adhesion of cultured angiogenic cells to vascular smooth muscle cells
Number of cells adhering
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJun 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Birch, University of Leeds
- Investigators
- Karen M Birch, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853279
- Sponsor's protocol ID
- BIOSCI 10-021
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 2 Aug 2016
- 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 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of (i) Physical Activity and (ii) Continuous Versus Intermittent Exercise Training Upon Cardiovascular and Cognitive Function in Obese Women
- ClinicalTrials.gov ID
- NCT02853279
- Acronym / sponsor ID
- BIOSCI 10-021
- Conditions
- Obesity, Cognitive Ability, General, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Aug 2016 (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.
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Written informed consent will be gained following greater than 48 hours for the purpose of reading the Participant Information sheets. The study will then involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers (i.e. participants who volunteer to exercise train). Participants for stage 1 will then visit the laboratory in the University on three occasions (over a three week period) to be assessed for body composition, exercise tolerance, current physical activity levels, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who have volunteered for the exercise training component (approx 60). These participants will then be randomly divided into two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner at a moderate intensity, whilst the second group will exercise at a heavy intensity but in short bursts. Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
Detailed description
The study will involve two stages (i) recruiting participants for a cross sectional analysis of the relationship between physical activity levels and cardiovascular and cognitive function, and (ii) a longer exercise training study in a subsample of these volunteers. 100 participants for stage 1 will visit the laboratory in the University on three occasions (within a three week period) to be assessed for anthropometric outcomes, body composition, exercise tolerance, cognitive function and arterial and cardiac health. Each visit will last for 60 - 90 minutes. Participants will then be provided with an accelerometer to wear for a period of one week in order to assess movement counts and sedentary behaviour. Stage 2 will include only those participants who are happy to continue into the exercise training phase. These participants will then be matched for age and BMI and then randomly (on matched pairs) allocated to one of two groups. Both groups will exercise three times per week for 12 weeks duration. Group 1 will exercise in a traditional manner undertaking continuous exercise, whilst the Group 2 will exercise at a heavy intensity but in short bursts (interval exercise). Both groups will complete the same amount of work but in two differing modes. Both groups will attend the laboratory twice per week for supervised exercise sessions and also perform one home based 30 minute brisk walk per week. All participants will be re-examined at 12 weeks.
Recruitment of participants
One hundred participants from a combination of (a) local advertisements and/or (b) those whose details are held on a research database (of previous volunteers indicating willingness to be contacted about future studies) will be sought to volunteer for this study. Participants will be contacted via email/telephone/letter to provide information regarding this study. All volunteers interested in participating will be contacted to provide general information during a preliminary telephone screening interview. This will be used to check main inclusion and exclusion criteria. The women who fit these criteria will be sent the participant information sheet to read carefully and if still interested invited to attend the first laboratory visit for a screening session. Participants have greater than 48 hours to assess the participant information sheet before they attend this first visit when, if eligible, they will be asked to provide written informed consent.
Laboratory Visits
Visit 1
During this visit the study and all procedures will be explained in detail to all participants, and written informed consent will be taken. A thorough medical history will be obtained and participants will be asked to complete a Recruitment Information Questionnaire (RIQ) to confirm all inclusion/ exclusion criteria. Participants will complete the National Adult Reading Test (NART) which estimates premorbid intelligence levels.
Participants will also complete a Physical Activity Readiness Questionnaire (PAR-Q) which will be reviewed to determine whether participants are fit to continue with the study. Simple measures of body weight, height and waist circumference will be taken. Participants will complete a practice version of the cognitive test battery to demonstrate the tests, ensure participants understand how to perform the tests correctly and assess compliance (effort).
Participants will complete a cycling test on a stationary bicycle under the supervision of the investigator and a medic.
Visit 2
The second visit will involve several measures of arterial health which requires participants to attend in a 12 hour fasted state. Blood vessel function will be assessed using a blood pressure cuff around the lower arm for a period of 5 minutes. Cardiac structure and function will be assessed using two-dimensional (2D) echocardiography. Vascular function will be assessed using ultrasound and applanation tonometry. All procedures are non-invasive. Percentages of body fat and muscle mass will be measured using bioimpedance.
A 60ml blood sample will be taken which will be used to asses endothelial progenitor cell number and function, insulin sensitivity, cholesterol levels and is part of the assessment for health of the arteries and vascular system.
Visit 3
On the third visit a cognitive function test will be completed, which requires participants to attend in a 12 hour fasted state.
Participants will perform a 45 minute battery of cognitive tests. Following the cognitive tests, participants will be asked to complete a cognitive test evaluation questionnaire to assess both subjective and objective cognition.
At the end of the third laboratory visit all participants will be provided with an ActiHeart accelerometer (Actigraph, Pensacola, USA) to wear for a period of one week in order to assess movement counts and sedentary behaviour. At the end of the seven days the accelerometer is given back to or collected by the team and the data downloaded.
The three baseline laboratory visits plus the seven days using the ActiHeart accelerometer all come under stage 1 of the study. Participants will be asked to continue into the exercise training stage (stage 2), and willing volunteers will move through to the second stage of the experiment. All measures will be repeated at 12 weeks (78 hours to 5 days following cessation of the last exercise training session).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval exercise training | Experimental | Behavioral: Interval exercise trainingSupervised exercise training undertaking interval exercise twice per week for 30 min each visit over 12 weeks. |
| Continuous exercise training | Active comparator | Behavioral: Continuous exercise training (CON)Supervised exercise training undertaking continuous exercise twice per week for 30 min each visit over 12 weeks. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sedentary women (exercise ≤2 day per week)
- Pre-menopausal (age 35- 50 years)
- BMI of ≥30 kg/m2
- Able to give informed consent .
- Non-smokers
Key exclusion criteria (14 listed)
- Male
- BMI < 30 kg/m2
- Clinically diagnosed with type 1 or type 2 diabetes
- Resting/exercise ECG indicating significant ischemia, recent myocardial infarction or other acute cardiac event or other exercise related ECG abnormalities.
- Unstable angina.
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 |
|---|---|---|
| Interval exercise trainingInterval exercise sessions (INT) involving work:recovery ratios of 40 s at 70% delta work-rate followed by 80 s active recovery at 20 W. 70% delta (∆) is 70% of the difference between work rate peak (WRpeak) and work rate at the lactate threshold (WRLT) calculated as: 70%∆ =0.7(〖WR〗_peak- 〖WR〗_LT )+ 〖WR〗_LT Where WR is work rate, LT is lactate threshold) Each session was for 30 min and this was undertaken twice per week for 12 weeks. One home based exercise session was incorporated per week. | Behavioural | Interval exercise training |
| Continuous exercise training (CON)Exercise sessions involved cycling at 20%∆ work-rate peak for the duration of the session. This work-rate was chosen so that all participants in the group would be exercising in the heavy-intensity domain. To enable participants in the CON exercise group to complete the same amount of work (kJ) as the participants in the INT exercise group, the amount of work that would be completed if the CON participants completed an INT exercise session was calculated. Participants exercised for 26 min (varying to match interval group) twice per week for 12 weeks. | Behavioural | Continuous exercise training |
Primary outcome
Maximal oxygen uptake (CPX)
Time frame: Change at 12 weeks
Maximal oxygen uptake assessed during a ramp incremental cycle ergometry test.
Flow mediated dilatation
Time frame: Change at 12 weeks
Percentage change in brachial artery diameter following cuff occlusion using doppler ultrasound.
19 secondary outcomes
Lactate threshold
Time frame: Baseline and 12 weeks
Blood borne (plasma) inflammatory marker
Time frame: Baseline and 12 weeks
Work rate peak
Time frame: Baseline and 12 weeks
Circulating angiogenic cell number
Time frame: Baseline and 12 weeks
Circulating cytokines
Time frame: Baseline and 12 weeks
Circulating cytokines
Time frame: Baseline and 12 weeks
Arterial stiffness
Time frame: Baseline and 12 weeks
Cognitive function (Visual spatial learning scale)
Time frame: Baseline and 12 weeks
Cognitive function (Tower of Hanoi)
Time frame: Baseline and 12 weeks
Cognitive function (Grooved peg board)
Time frame: Baseline and 12 weeks
Cognitive function (Visual verbal learning scale)
Time frame: Baseline and 12 weeks
Cognitive function (Bakan test))
Time frame: Baseline and 12 weeks
Cognitive function (Corsi block tapping)
Time frame: Baseline and 12 weeks
Physical activity level
Time frame: Baseline and 12 weeks
Blood pressure
Time frame: Baseline and 12 weeks
Body composition
Time frame: Baseline and 12 weeks
Cardiac function (echocardiography)
Time frame: Baseline and 12 weeks
Cardiac structure (echocardiography)
Time frame: Baseline and 12 weeks
Adhesion of cultured angiogenic cells to vascular smooth muscle cells
Time frame: Baseline and 12 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 2 Aug 2016.
- 3 abstracts presented to the annual congress of the European College of Sports and Exercise Sciences, Barcelona, Spain, 2013Link 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.
Karen M Birch, PhD principal investigator
University of Leeds
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interval exercise training and Continuous exercise training (CON) in people with Obesity and Cognitive Ability, General, run by University of Leeds at 2 sites in United Kingdom.
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 6 inclusion and 14 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Maximal oxygen uptake (CPX) (time frame: Change at 12 weeks). 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 2 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.