Chronic Obstructive Pulmonary DiseasePhase 2MorExNCT03824834
Morphine to Maximize the Benefits of Exercise Training in COPD or ILD and Persistent Breathlessness
A Phase 2 study testing Exercise training with morphine in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by Dennis Jensen, Ph.D. at 1 site in Canada.
Trial summary
The purpose of this study is to explore the role of low-dose immediate-release oral morphine as a novel adjunct pharmacotherapy to enable symptomatic adults with advanced chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) to exercise at higher intensities for longer durations and maximize… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- What is being tested?
- Exercise training with morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 6 Aug 2019to Nov 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 35 years and over
- Clinical diagnosis of COPD or ILD
- Cigarette smoking history ≥20 years (COPD only)
- Post bronchodilator FEV1 <50% predicted and FEV1/FVC <0.70 (COPD only)
- Chronic breathlessness syndrome (modified Medical Research Council dyspnea score ≥3; Baseline Dyspnea Index focal score ≤6; and/or an Oxygen Cost Diagram rating ≤50% full scale despite optimal treatment of the underlying pathophysiology according to evidence-based clinical practice guidelines
- Report breathlessness as the main limiting factor to incremental CPET
- Body mass index >18.5 kg/m2 and <35 kg/m2
Who cannot join
- Changed respiratory medication dosage and/or frequency of administration in preceding two weeks
- Disease exacerbation/hospitalization in preceding six weeks
- Arterialized capillary CO2 tension (PacCO2) >50 mmHg at rest
- Self-reported history of drug addiction and/or substance abuse assessed with the CAIG-aid and SISAP questionnaires
- Severe excessive daytime sleepiness assessed with the Epworth Sleepiness Scale (score of 16 out of 24)
- Currently use anti-seizure and/or opioid drug(s)
Show all 15Show fewer
- Use daytime supplemental oxygen
- Exercise-induced oxyhemoglobin desaturation to <80% on room air
- Participated in a pulmonary rehabilitation program in preceding 6 months
- Allergy/sensitivity to opioid drugs
- Significant extra-pulmonary disease that could impair exercise tolerance
- Contraindication(s) to cardiopulmonary exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease)
- Pregnant or currently trying to become pregnant: women of child bearing potential (defined as having a menstrual period within the last 12 months) will be required to take a routine (urine) pregnancy test to rule out the possibility of pregnancy
- Self-report any of the following conditions: anemia or abnormally low blood volume; asthma; hypothyroidism; Addison's disease; renal insufficiency; hypopituitarism; severe malnutrition; digestive disease (any form of colitis disease); prostatic hypertrophy or urethral stricture
- Use of the blood thinning (anti-coagulant) drug Coumadin, Pradaxa, Xarelto and Eliquis in previous 2 weeks
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal Chest Institute of the McGill University Health Center (MUHC)
Montreal, Quebec, H4A 3J1
Dennis Jensen, Ph.D., 514-398-4184 ext. 0541, dennis.jensen@mcgill.ca
Hayley Lewthwaite, Ph.D, 514-398-4184 ext. 09081, hayley.lewthwaite@mail.mcgill.ca
About this study
Official title: Morphine: a Novel Intervention to Maximize the Benefits of Exercise Training in Adults With Chronic Lung Disease and Persistent Breathlessness?
The purpose of this study is to explore the role of low-dose immediate-release oral morphine as a novel adjunct pharmacotherapy to enable symptomatic adults with advanced chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a supervised exercise training program. We hypothesize that, compared to placebo, exercise training with oral morphine will result in relatively greater improvements in exercise endurance time and intensity ratings of perceived breathlessness during constant-load cardiopulmonary cycle exercise testing (CPET) at 75% of peak power output (PPO).
Read the detailed description
Supervised exercise training programs (such as pulmonary rehabilitation) are an integral component of the clinical management of COPD or ILD; a proven intervention for improving symptom burden, quality of life, emotional function, exercise capacity, and risk of hospitalization and death. While both low and high intensity exercise training benefits adults with COPD or ILD, evidence supports that higher intensity exercise training produces relatively greater physiological and symptomatic improvements. High intensity exercise of adequate duration is, however, difficult and unpleasant for people with COPD or ILD due to heightened exertional symptoms, particularly breathlessness.These symptoms persist despite the patient's underlying disease being optimally managed according to evidence-based clinical practice guideline standards.
Low-dose immediate-release oral morphine has recently shown promise as a novel adjunct therapy to reduce exertional breathlessness and increase exercise endurance time in people with advanced chronic lung disease (COPD). The purpose of this randomized, double-blind, placebo-controlled, two-arm pilot study is to further explore the role of low-dose immediate-release oral morphine as an adjunct pharmacotherapy to enable symptomatic adults with advanced COPD or ILD to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a 5-week supervised exercise training program.
Adults with a clinical diagnosis of COPD or ILD and chronic breathlessness syndrome will be randomized in a 1:1 ratio to exercise training with oral morphine (ExT+MOR) (n=20; 10 COPD and 10 ILD) or exercise training with placebo (diluted simple syrup) (ExT+PLA) (n=20; 10 COPD and 10 ILD). All eligible participants will complete four assessment visits (Visits 1, 2, 3 and 4) and 15 exercise training (T1-15) sessions. Assessment Visits 1 and 3 will include post-bronchodilator (400 mg Salbutamol) pulmonary function testing and a symptom-limited incremental cardiopulmonary exercise test (CPET) to determine peak power output (PPO). Visits 2 and 4 will include a symptom-limited constant-load CPET at 75% of the PPO determined at Visit 1 and a dual energy x-ray absorptiometry (DEXA) scan to assess body composition. Supervised exercise training will be performed three times per week for five weeks on an electronically braked cycle ergometer, supervised by a trained exercise specialist. Exercise sessions will be individualized based on participants' pre-defined PPO (initial intensity of 60% PPO), and progressed to ensure the participant is exercising at an intensity corresponding to a breathlessness intensity rating of between 3-5 Borg 0-10 category ratio scale (CR10) units and can complete at least 20-min of continuous cycling. Exercise duration will be increased in 5-min intervals up to 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline PPO.
- Being tested
- Exercise training with morphine, Exercise training with placebo
- Keywords
- Breathlessness, Dyspnea, Exercise, Opioids, Morphine, Exercise tolerance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training with morphineDrug
Immediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions (three times per week for five weeks) on an electronically braked bike, supervised by a trained exercise specialist. Exercise sessions will be individualized based on participants' peak power output (60% PPO) determined from incremental exercise testing, and progressed to ensure the participant is exercising at a breathlessness intensity rating of between 3-5 Borg CR10 scale units and can complete at least 20-min of continuous cycling. Exercise duration will be increased in 5-min intervals up to 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline PPO.
Exercise training with placeboOther
Diluted simple syrup prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions as per the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training with morphine | Experimental | Immediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) with supervised exercise training. Receives: Drug: Exercise training with morphine |
| Exercise training with placebo | Placebo comparator | Placebo treatment with supervised exercise training. Receives: Other: Exercise training with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary exercise testing (CPET) endurance time
Cardiopulmonary exercise testing (constant-load) will be used to assess change in endurance time pre to post intervention. Endurance time will be defined as the total duration of loaded pedalling (minutes).
Measured: Immediately after exercise training program
Borg modified 0-10 category ratio scale (Borg CR10) for breathlessness intensity
Borg modified 0-10 category ratio scale (Borg CR10) will be used to assess breathlessness intensity during constant-load CPET at isotime, defined as the highest equivalent 2-min interval of exercise completed by a given participant during each of the constant-load CPETs.
Measured: Immediately after exercise training program
Secondary outcomes (11)
Short Form Health Survey (SF-36) for quality of life
Short Form Health Survey (SF-36) will be used to assess change in quality of life pre to post intervention.
Measured: Immediately after exercise training program
Multidimensional Dyspnoea Profile for 'usual' breathlessness
Multidimensional Dyspnoea Profile will be used to assess change in 'usual' breathlessness pre to post intervention.
Measured: Immediately after exercise training program
Hospital Anxiety and Depression Scale (HADS) for anxiety and depressive symptoms
Hospital Anxiety and Depression Scale (HADS) will be used to assess change in anxiety and depressive symptoms pre to post intervention.
Measured: Immediately after exercise training program
DEXA-derived body composition
DEXA will be used to assess change in fat free mass pre to post intervention. Fat free mass will be expressed as fat free mass index, which is the fat free mass per kg of total body weight per metre squared of standing height.
Measured: Immediately after exercise training program
CPET physiological response (gas exchange)
Breath-by-breath CPET (incremental) parameters will be averaged in 30-sec intervals at rest and during exercise. The change in peak volume of oxygen consumption pre to post will be reported.
CPET parameters will be collected over the first 30-sec period of every second minute during exercise. Three main time points will be used to evaluate exercise test parameters: (1) pre-exercise rest, defined as the steady-state period after at least 3-min of breathing on the mouthpiece while seated at rest before exercise; (2) isotime (as defined above); and (3) peak exercise, defined as the average of the last 30-sec of loaded pedaling.
Measured: Immediately after exercise training program
CPET physiological response (power output)
Breath-by-breath CPET (incremental) parameters will be averaged in 30-sec intervals at rest and during exercise. The change in peak power output pre to post will be reported.
CPET parameters will be collected over the first 30-sec period of every second minute during exercise. Three main time points will be used to evaluate exercise test parameters: (1) pre-exercise rest, defined as the steady-state period after at least 3-min of breathing on the mouthpiece while seated at rest before exercise; (2) isotime (as defined above); and (3) peak exercise, defined as the average of the last 30-sec of loaded pedaling.
Measured: Immediately after exercise training program
Minimal clinically important difference breathlessness intensity
The proportion of participants meeting or exceeding the minimal clinically important difference of ≥1 Borg CR10 scale units in breathlessness intensity at isotime
Measured: Immediately after exercise training program
Minimal clinically important difference exercise endurance
The proportion of participants meeting or exceeding the minimal clinically important difference of ≥101-sec for exercise endurance time at isotime
Measured: Immediately after exercise training program
Safety measures - Arterialized carbon dioxide
Pre to post treatment differences in arterialized carbon dioxide assessed with a blood sample from the warmed earlobe.
Measured: Immediately after each treatment
Safety measures - Opioid-Related Symptom Distress Scale (ORSDS)
Pre to post treatment differences in ORSDS-derived measures of opioid-related side-effects
Measured: Immediately after each treatment
Safety measures - Adverse events
The number of participants reporting adverse events (serious and non serious).
Measured: Immediately after exercise training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start6 Aug 2019
- Primary completionJun 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dennis Jensen, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, Ph.D, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824834
- Sponsor's protocol ID
- MorEX_2019-5261
- Acronym
- MorEx
- Status last verified
- Aug 2019
- First submitted
- 28 Jan 2019
- Last updated
- 16 Aug 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 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphine: a Novel Intervention to Maximize the Benefits of Exercise Training in Adults With Chronic Lung Disease and Persistent Breathlessness?
- ClinicalTrials.gov ID
- NCT03824834
- Acronym / sponsor ID
- MorEx / MorEX_2019-5261
- Keywords
- Breathlessness, Dyspnea, Exercise, Opioids, Morphine, Exercise tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dennis Jensen, Ph.D.University, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 31 Jan 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.
The purpose of this study is to explore the role of low-dose immediate-release oral morphine as a novel adjunct pharmacotherapy to enable symptomatic adults with advanced chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a supervised exercise training program. We hypothesize that, compared to placebo, exercise training with oral morphine will result in relatively greater improvements in exercise endurance time and intensity ratings of perceived breathlessness during constant-load cardiopulmonary cycle exercise testing (CPET) at 75% of peak power output (PPO).
Detailed description
Supervised exercise training programs (such as pulmonary rehabilitation) are an integral component of the clinical management of COPD or ILD; a proven intervention for improving symptom burden, quality of life, emotional function, exercise capacity, and risk of hospitalization and death. While both low and high intensity exercise training benefits adults with COPD or ILD, evidence supports that higher intensity exercise training produces relatively greater physiological and symptomatic improvements. High intensity exercise of adequate duration is, however, difficult and unpleasant for people with COPD or ILD due to heightened exertional symptoms, particularly breathlessness.These symptoms persist despite the patient's underlying disease being optimally managed according to evidence-based clinical practice guideline standards.
Low-dose immediate-release oral morphine has recently shown promise as a novel adjunct therapy to reduce exertional breathlessness and increase exercise endurance time in people with advanced chronic lung disease (COPD). The purpose of this randomized, double-blind, placebo-controlled, two-arm pilot study is to further explore the role of low-dose immediate-release oral morphine as an adjunct pharmacotherapy to enable symptomatic adults with advanced COPD or ILD to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a 5-week supervised exercise training program.
Adults with a clinical diagnosis of COPD or ILD and chronic breathlessness syndrome will be randomized in a 1:1 ratio to exercise training with oral morphine (ExT+MOR) (n=20; 10 COPD and 10 ILD) or exercise training with placebo (diluted simple syrup) (ExT+PLA) (n=20; 10 COPD and 10 ILD). All eligible participants will complete four assessment visits (Visits 1, 2, 3 and 4) and 15 exercise training (T1-15) sessions. Assessment Visits 1 and 3 will include post-bronchodilator (400 mg Salbutamol) pulmonary function testing and a symptom-limited incremental cardiopulmonary exercise test (CPET) to determine peak power output (PPO). Visits 2 and 4 will include a symptom-limited constant-load CPET at 75% of the PPO determined at Visit 1 and a dual energy x-ray absorptiometry (DEXA) scan to assess body composition. Supervised exercise training will be performed three times per week for five weeks on an electronically braked cycle ergometer, supervised by a trained exercise specialist. Exercise sessions will be individualized based on participants' pre-defined PPO (initial intensity of 60% PPO), and progressed to ensure the participant is exercising at an intensity corresponding to a breathlessness intensity rating of between 3-5 Borg 0-10 category ratio scale (CR10) units and can complete at least 20-min of continuous cycling. Exercise duration will be increased in 5-min intervals up to 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline PPO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training with morphine | Experimental | Drug: Exercise training with morphineImmediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) with supervised exercise training. |
| Exercise training with placebo | Placebo comparator | Other: Exercise training with placeboPlacebo treatment with supervised exercise training. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females aged 35 years and over
- Clinical diagnosis of COPD or ILD
- Cigarette smoking history ≥20 years (COPD only)
- Post bronchodilator FEV1 <50% predicted and FEV1/FVC <0.70 (COPD only)
- Chronic breathlessness syndrome (modified Medical Research Council dyspnea score ≥3; Baseline Dyspnea Index focal score ≤6; and/or an Oxygen Cost Diagram rating ≤50% full scale despite optimal treatment of the underlying pathophysiology according to evidence-based clinical practice guidelines
Key exclusion criteria (15 listed)
- Changed respiratory medication dosage and/or frequency of administration in preceding two weeks
- Disease exacerbation/hospitalization in preceding six weeks
- Arterialized capillary CO2 tension (PacCO2) >50 mmHg at rest
- Self-reported history of drug addiction and/or substance abuse assessed with the CAIG-aid and SISAP questionnaires
- Severe excessive daytime sleepiness assessed with the Epworth Sleepiness Scale (score of 16 out of 24)
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 training with morphineImmediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions (three times per week for five weeks) on an electronically braked bike, supervised by a trained exercise specialist. Exercise sessions will be individualized based on participants' peak power output (60% PPO) determined from incremental exercise testing, and progressed to ensure the participant is exercising at a breathlessness intensity rating of between 3-5 Borg CR10 scale units and can complete at least 20-min of continuous cycling. Exercise duration will be increased in 5-min intervals up to 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline PPO. | Drug | Exercise training with morphine |
| Exercise training with placeboDiluted simple syrup prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions as per the experimental group. | Other | Exercise training with placebo |
Primary outcome
Cardiopulmonary exercise testing (CPET) endurance time
Time frame: Immediately after exercise training program
Cardiopulmonary exercise testing (constant-load) will be used to assess change in endurance time pre to post intervention. Endurance time will be defined as the total duration of loaded pedalling (minutes).
Borg modified 0-10 category ratio scale (Borg CR10) for breathlessness intensity
Time frame: Immediately after exercise training program
Borg modified 0-10 category ratio scale (Borg CR10) will be used to assess breathlessness intensity during constant-load CPET at isotime, defined as the highest equivalent 2-min interval of exercise completed by a given participant during each of the constant-load CPETs.
11 secondary outcomes
Short Form Health Survey (SF-36) for quality of life
Time frame: Immediately after exercise training program
Multidimensional Dyspnoea Profile for 'usual' breathlessness
Time frame: Immediately after exercise training program
Hospital Anxiety and Depression Scale (HADS) for anxiety and depressive symptoms
Time frame: Immediately after exercise training program
DEXA-derived body composition
Time frame: Immediately after exercise training program
CPET physiological response (gas exchange)
Time frame: Immediately after exercise training program
CPET physiological response (power output)
Time frame: Immediately after exercise training program
Minimal clinically important difference breathlessness intensity
Time frame: Immediately after exercise training program
Minimal clinically important difference exercise endurance
Time frame: Immediately after exercise training program
Safety measures - Arterialized carbon dioxide
Time frame: Immediately after each treatment
Safety measures - Opioid-Related Symptom Distress Scale (ORSDS)
Time frame: Immediately after each treatment
Safety measures - Adverse events
Time frame: Immediately after exercise training program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill UniversityLink 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.
Dennis Jensen, Ph.D principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise training with morphine in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by Dennis Jensen, Ph.D. at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Jensen, Ph.D (514-398-4184 ext. 0541, denis.jensen@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise testing (CPET) endurance time (time frame: Immediately after exercise training program). 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 16 Aug 2019.