Pulmonary Disease, Chronic ObstructiveCOPDNCT01354067
Single Limb Resistance Training in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing High-repetitive single limb training in people with Pulmonary Disease, Chronic Obstructive, run by Umeå University at 2 sites in Sweden.
Trial summary
The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients resulting in increased dyspnea during physical activity restricts many COPD patients ability to perform exercises in general and whole-body exercises in particular. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- High-repetitive single limb training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesSweden
- Study dates
- May 2011to Jun 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 40 years and above.
- Stable (no exacerbations within 4 weeks before start of baseline testing) moderate to very severe COPD, stage II-IV, according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.70, FEV1 < 80% predicted.
- Ex-smoker.
- Stable medical treatment (no changes < 4 weeks before start of baseline testing).
- Living less than 60 km from training facility.
Who cannot join
- Musculoskeletal, rheumatic, cardiac or neurological disorders that might affect the exercise performance in training and tests.
- Previous lung surgery.
- Acute exacerbations of COPD that require a change in pharmacological management within four weeks preceding the start of the intervention
- Long-term oxygen treatment.
- Participated in organized exercise training, > 2 times a week, within 6 months before start of intervention.
- Body mass index (BMI) < 18 kg/m2.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Huddinge University Hospital
Huddinge, 141 59
Umeå University Hospital
Umeå, 90187
About this study
Official title: Effects of High-repetitive Single Limb Training on Exercise Capacity and Quality of Life in Patients With COPD Compared to a Control Group - A Prospective, Single Blind, Randomized Controlled Multicenter Trial
The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients resulting in increased dyspnea during physical activity restricts many COPD patients ability to perform exercises in general and whole-body exercises in particular. Single limb training performed as one-legged cycling has been shown effective in patients with COPD. This exercise regime results in less stress on the ventilatory system as training is executed using a simultaneously smaller muscle mass. However, the positive physiological effects of exercise training only occur in the involved muscle(s). To be of benefit for patients daily life, all relevant muscles should be included in exercise training. The aim of the current randomized controlled multicenter trial (RCT) is to determine the effects of high-repetitive single limb exercises (HRSLE) in combination with COPD specific patient education, compared to the COPD specific patient education alone in patients with moderate to very severe (stage II-IV) COPD.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality in the world. It is one of our most common chronic diseases and up to 700.000 people is estimated to suffer from COPD in Sweden. Exercise intolerance is the key disabling factor in COPD, with decreased exercise capacity, leg fatigue and dyspnea among the most frequently reported symptoms.
Different training modalities have been evaluated to uncover the most effective way of training patients with COPD. Traditionally research has used whole-body, or major muscle mass training regimes when investigating the effect of both endurance and resistance in COPD patients. However recent research have demonstrated positive effects using training regimes involving a simultaneous smaller muscle mass compared to traditional exercise. The concept of using this regime is to put less stress on the ventilator system when exercising to minimize the effect of the chronic airflow limitation and to enhance the ability to be able to exercise for this group of patients compared to traditional training using major muscle mass exercise regimes. Although recent research have shown positive effects of single limb training using one-legged cycling, one major limitation is that only a small amount of important muscles for COPD patients are incorporated. Therefore, the aim of this study is to: (i) examine the effect of a single limb exercise regime on local muscle endurance, maximal strength, quality of life, dyspnea, walking capacity, self-efficacy, anxiety and depression, (ii) to examine if the physiological effects differ between man and women and (iii) to investigate if this exercise regime is feasible and safe to use for patients with COPD.
Patients diagnosed with moderate to very severe COPD according to GOLD criteria will be randomly assigned to constitute either an exercise or control group The exercise group will participate in a high-repetitive single limb exercise regime, consisting of upper and lower limb exercises with elastic resistance, compromised of three sessions per week over a period of 8 weeks. The exercise regime will be performed in group at Umeå University Hospital of Northern Sweden, and at Huddinge University Hospital, Sweden supervised by experienced physiotherapists. Both the exercise and control group will receive four sessions of standardized patient education during the 8 week intervention period. After completion of the study, patients in the control group will be offered participation in the single limb exercise regime.
The most important upper and lower extremity muscles for COPD patients are identified and exercises are designed specific to each of these. The exercise regime consists of 8 exercises, 4 upper extremity and 4 lower extremity exercises. Starting position and performance of the exercises are standardized and the resistance individually adjusted and progressed according to rated dyspnea and muscle fatigue.
Before and after the 8 week intervention period the following information will be collected. Effects on maximal strength, muscular endurance, dyspnea, self-efficacy, anxiety and depression. The relationship between changes in health related variables and changes in exercise capacity, sex related differences in training effects, feasibility of the program, strategies to determine adequate starting resistance and provide accurate resistance for each involved movement and the relationship between muscle fatigue and dyspnea in the different exercise tests will also be analyzed.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Control group, High-repetitive single limb training
- Keywords
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Single Limb, Elastic Resistance, Resistance Training, Minor Muscle Mass, Local muscle training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupBehavioural
The control group receives standardized patient education four times, once every two weeks, during the eight week intervention period. Each session will last 60 minutes, consisting of information regarding anatomy, physiology, causes and mechanisms of COPD, drugs, nutrition, aids and energy saving procedures. The information is the same as for the intervention group, given at separate occasions.
High-repetitive single limb trainingBehavioural
The high-repetitive single limb exercise regime consists of three sessions per week during eight weeks of exercise training, giving a total number of 24 sessions at each location (Umeå and Huddinge University hospitals). The exercise sessions are supervised and conducted by a physical therapist using a group format, six to eight participants in each group. Each session will span for 60 minutes, duration of the major components are: 10 min warm-up followed by 40 minutes of single limb training and 10min cool-down. In addition this experimental group also receives four sessions of patient education once every two week.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will receive standardized patient education four times, once every two weeks, during the eight week intervention period. Receives: Behavioral: Control group |
| High-repetitive single limb training | Experimental | The experimental group will receive a high-repetitive single limb exercise regime, three times a week for two months. In addition, the exercise group will receive patient education at four occasions during the intervention period. Receives: Behavioral: High-repetitive single limb training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
The Swedish Self-Administered Standardized version of the Chronic Respiratory Disease Questionnaire (CRQ-SAS) will be used as primary outcome measure to asses quality of life
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Functional lower extremity muscular endurance
To asses muscular endurance in the lower extremity the 6-minute walk test will be used as primary outcome measure.
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Upper extremity muscular endurance
The 6-minute ring and pegboard test will be used as primary outcome measure for upper extremity muscular endurance
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Secondary outcomes (12)
Isokinetic maximal muscle strength
Maximal muscle strength in both upper and lower extremity will be evaluated with an isokinetic dynamometer
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Upper extremity muscular endurance
The Unsupported Upper Limb Exercise test will be used as secondary outcome measure for upper extremtiy muscular endurance
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Isokinetic muscular endurance capacity
Endurance capacity in both upper and lower extremity will be evaluated with an isokinetic dynamometer
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Self-efficacy
Self-efficacy will be evaluated with the exercise self-efficacy scale, and the self-efficacy for walking questionnaire
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Anxiety and Depression
Anxiety and Depression will be evaluated with the hospital anxiety and depression scale (HADs)
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Relationship between muscle fatigue and dyspnea in the different exercise tests
Muscle fatigue and dyspnea will be measured using the BORG CR10 scale during all exercise tests before the start of the study and on completion 8 weeks later. The relationship between ratings of muscle fatigue between tests, dyspnea between tests and the relationship between muscle fatigue rating and dyspnea rating between exercise tests will be investigated.
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Develop a strategy to optimize resistance for each involved movement within an exercise regimen
The exercises used within the intervention group is performed with elastic resistance. How much the elastic band is stretched for the different exercises is determined by a literature search investigation the strenght relationship between the muscles/movements used in the study. During the study each participant in the intervention group will rate muscle fatigue and dyspnea after each exercise during alla exercise sessions. These rating will be used to develop a strategy to optimize resistance for each involved movement within an exercise regimen
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Develop a strategy to minimize attempts needed to determine a multiple repetition resistance using elastic bands
55% of the isokinetic peak value obtained during baseline tests will be used to anticipate the 25RM load when using elastic resistance in an attempt to minimize the attempts needed to achieve 25RM.
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Determine if this exercise regimen is feasible and safe in stage II-IV COPD patients
Feasibility will be evaluated through number of participants attendance, adherence and number of participants developing any side effects or injuries during each training session. In addition, compliance to the different parts of the exercise regimen will be evaluated with a standardized questionnaire by both study participants and physiotherapists leading interventions.
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Identify if there are any sex related differences in exercise training effects
Statistical analyzes will be used to identify if there are any sex related differences in exercise training effects between male and female patients with COPD
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Quality-of-life
The clinical COPD questionnaire (CCQ) and the SF-36 scale will be used as secondary outcome measures for Quality-of-life
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Exercise capacity
A constant work rate test investigating the effects on endurance time, ventilatory response, perceived dyspnea and leg fatigue during submaximal cycle test.
Measured: Before single limb exercise regime and on completion (at 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karin Wadell, Umeå University
- Investigators
- Karin Wadell, Ph.D, Principal investigator, Umeå UniversityAndre Nyberg, Msc, Study chair, Umeå UniversityBritta Lindström, Ph.D, Study chair, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354067
- Sponsor's protocol ID
- LHM-2011-ANKW
- Acronym
- COPD
- Status last verified
- Jun 2012
- First submitted
- 11 May 2011
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nyberg A, Lindstrom B, Wadell K. Assessing the effect of high-repetitive single limb exercises (HRSLE) on exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD): study protocol for randomized controlled trial. Trials. 2012 Jul 23;13:114. doi: 10.1186/1745-6215-13-114.
PubMed 22823966
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-repetitive Single Limb Training on Exercise Capacity and Quality of Life in Patients With COPD Compared to a Control Group - A Prospective, Single Blind, Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01354067
- Acronym / sponsor ID
- COPD / LHM-2011-ANKW
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Single Limb, Elastic Resistance, Resistance Training, Minor Muscle Mass, Local muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 May 2011 (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.
The chronic airflow limitation in chronic obstructive pulmonary disease (COPD) patients resulting in increased dyspnea during physical activity restricts many COPD patients ability to perform exercises in general and whole-body exercises in particular. Single limb training performed as one-legged cycling has been shown effective in patients with COPD. This exercise regime results in less stress on the ventilatory system as training is executed using a simultaneously smaller muscle mass. However, the positive physiological effects of exercise training only occur in the involved muscle(s). To be of benefit for patients daily life, all relevant muscles should be included in exercise training. The aim of the current randomized controlled multicenter trial (RCT) is to determine the effects of high-repetitive single limb exercises (HRSLE) in combination with COPD specific patient education, compared to the COPD specific patient education alone in patients with moderate to very severe (stage II-IV) COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality in the world. It is one of our most common chronic diseases and up to 700.000 people is estimated to suffer from COPD in Sweden. Exercise intolerance is the key disabling factor in COPD, with decreased exercise capacity, leg fatigue and dyspnea among the most frequently reported symptoms.
Different training modalities have been evaluated to uncover the most effective way of training patients with COPD. Traditionally research has used whole-body, or major muscle mass training regimes when investigating the effect of both endurance and resistance in COPD patients. However recent research have demonstrated positive effects using training regimes involving a simultaneous smaller muscle mass compared to traditional exercise. The concept of using this regime is to put less stress on the ventilator system when exercising to minimize the effect of the chronic airflow limitation and to enhance the ability to be able to exercise for this group of patients compared to traditional training using major muscle mass exercise regimes. Although recent research have shown positive effects of single limb training using one-legged cycling, one major limitation is that only a small amount of important muscles for COPD patients are incorporated. Therefore, the aim of this study is to: (i) examine the effect of a single limb exercise regime on local muscle endurance, maximal strength, quality of life, dyspnea, walking capacity, self-efficacy, anxiety and depression, (ii) to examine if the physiological effects differ between man and women and (iii) to investigate if this exercise regime is feasible and safe to use for patients with COPD.
Patients diagnosed with moderate to very severe COPD according to GOLD criteria will be randomly assigned to constitute either an exercise or control group The exercise group will participate in a high-repetitive single limb exercise regime, consisting of upper and lower limb exercises with elastic resistance, compromised of three sessions per week over a period of 8 weeks. The exercise regime will be performed in group at Umeå University Hospital of Northern Sweden, and at Huddinge University Hospital, Sweden supervised by experienced physiotherapists. Both the exercise and control group will receive four sessions of standardized patient education during the 8 week intervention period. After completion of the study, patients in the control group will be offered participation in the single limb exercise regime.
The most important upper and lower extremity muscles for COPD patients are identified and exercises are designed specific to each of these. The exercise regime consists of 8 exercises, 4 upper extremity and 4 lower extremity exercises. Starting position and performance of the exercises are standardized and the resistance individually adjusted and progressed according to rated dyspnea and muscle fatigue.
Before and after the 8 week intervention period the following information will be collected. Effects on maximal strength, muscular endurance, dyspnea, self-efficacy, anxiety and depression. The relationship between changes in health related variables and changes in exercise capacity, sex related differences in training effects, feasibility of the program, strategies to determine adequate starting resistance and provide accurate resistance for each involved movement and the relationship between muscle fatigue and dyspnea in the different exercise tests will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Control groupThe control group will receive standardized patient education four times, once every two weeks, during the eight week intervention period. |
| High-repetitive single limb training | Experimental | Behavioral: High-repetitive single limb trainingThe experimental group will receive a high-repetitive single limb exercise regime, three times a week for two months. In addition, the exercise group will receive patient education at four occasions during the intervention period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 40 years and above.
- Stable (no exacerbations within 4 weeks before start of baseline testing) moderate to very severe COPD, stage II-IV, according to GOLD criteria i.e. Forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) < 0.70, FEV1 < 80% predicted.
- Ex-smoker.
- Stable medical treatment (no changes < 4 weeks before start of baseline testing).
- Living less than 60 km from training facility.
Key exclusion criteria (6 listed)
- Musculoskeletal, rheumatic, cardiac or neurological disorders that might affect the exercise performance in training and tests.
- Previous lung surgery.
- Acute exacerbations of COPD that require a change in pharmacological management within four weeks preceding the start of the intervention
- Long-term oxygen treatment.
- Participated in organized exercise training, > 2 times a week, within 6 months before start of intervention.
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 |
|---|---|---|
| Control groupThe control group receives standardized patient education four times, once every two weeks, during the eight week intervention period. Each session will last 60 minutes, consisting of information regarding anatomy, physiology, causes and mechanisms of COPD, drugs, nutrition, aids and energy saving procedures. The information is the same as for the intervention group, given at separate occasions. | Behavioural | Control group |
| High-repetitive single limb trainingThe high-repetitive single limb exercise regime consists of three sessions per week during eight weeks of exercise training, giving a total number of 24 sessions at each location (Umeå and Huddinge University hospitals). The exercise sessions are supervised and conducted by a physical therapist using a group format, six to eight participants in each group. Each session will span for 60 minutes, duration of the major components are: 10 min warm-up followed by 40 minutes of single limb training and 10min cool-down. In addition this experimental group also receives four sessions of patient education once every two week. | Behavioural | High-repetitive single limb training |
Primary outcome
Quality of life
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
The Swedish Self-Administered Standardized version of the Chronic Respiratory Disease Questionnaire (CRQ-SAS) will be used as primary outcome measure to asses quality of life
Functional lower extremity muscular endurance
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
To asses muscular endurance in the lower extremity the 6-minute walk test will be used as primary outcome measure.
Upper extremity muscular endurance
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
The 6-minute ring and pegboard test will be used as primary outcome measure for upper extremity muscular endurance
12 secondary outcomes
Isokinetic maximal muscle strength
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Upper extremity muscular endurance
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Isokinetic muscular endurance capacity
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Self-efficacy
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Anxiety and Depression
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Relationship between muscle fatigue and dyspnea in the different exercise tests
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Develop a strategy to optimize resistance for each involved movement within an exercise regimen
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Develop a strategy to minimize attempts needed to determine a multiple repetition resistance using elastic bands
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Determine if this exercise regimen is feasible and safe in stage II-IV COPD patients
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Identify if there are any sex related differences in exercise training effects
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Quality-of-life
Time frame: Before single limb exercise regime and on completion (at 8 weeks)
Exercise capacity
Time frame: Before single limb exercise regime and on completion (at 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 21 Jun 2012.
- Derived from this study: PubMed 22823966Nyberg A, Lindstrom B, Wadell K. Assessing the effect of high-repetitive single limb exercises (HRSLE) on exercise capacity and quality of life in patients with chronic obstructive pulmonary disease (COPD): study protocol for randomized controlled trial. Trials. 2012 Jul 23;13:114. doi: 10.1186/1745-6215-13-114.
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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.
Karin Wadell, Ph.D principal investigator
Umeå University
Andre Nyberg, Msc study chair
Umeå University
Britta Lindström, Ph.D study chair
Umeå University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-repetitive single limb training in people with Pulmonary Disease, Chronic Obstructive, run by Umeå University at 2 sites in Sweden.
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 5 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 21 Jun 2012. 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 Sweden. 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?
Quality of life (time frame: Before single limb exercise regime and on completion (at 8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354067, which also lists 1 linked publication.
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 21 Jun 2012.