StrokeNCT01777113
High Intensity Interval Training in Chronic Stroke Patients
A study testing High intensity aerobic training, High Intensity Strength Training and Mixed Training in people with Stroke, run by Universita di Verona at 2 sites in Italy.
Trial summary
Stroke is a global health-care problem that is common, serious and disabling. In most countries, stroke is second or third most common cause of death and one of the main causes of acquired adult disability. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- High intensity aerobic training, High Intensity Strength Training and Mixed Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2013to Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemical brain injury or intracerebral hemorrhage by MRI or computed tomography at least 6 months before the onset of the study;
- Ability to walk in the treadmill at >0.3 km/h for 3 minutes handrail support;
- Be able to give informed consent and be motivated to participate in 3- month intensive physical fitness training.
Who cannot join
- Mini Mental State Examination <20;
- Unstable angina pectoris;
- Unstable cardiac conditions;
- Complex ventricular arrhythmia;
- Resting systolic blood pressure >200 mm/Hg - Resting diastolic blood pressure >100 mm/Hg;
- Aphasia (unable to follow two commands);
- Other medical conditions precluding participation in aerobic exercise.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
S.S.O. di Riabilitazione dell'Ospedale Policlinico
Verona, Italy, 37134
Nicola Smania, Physician, 39 045 8124573, nicola.smania@univr.it
- Not yet recruiting
S.S.O. di Riabilitazione dell'Ospedale Policlinico
Verona, Verona, 37134
Nicola Smania, Physician, +39 045 8124573, nicola.smania@univr.it
Daniele Munari, Master, +39 045 8126499, daniele.munari@univr.it
About this study
Official title: The Effects of a High Intensity Gait Training in Improving Oxygen Consumption in Chronic Stroke Patients: a Randomized Control Study.
Stroke is a global health-care problem that is common, serious and disabling. In most countries, stroke is second or third most common cause of death and one of the main causes of acquired adult disability. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. After completion of conventional physical therapy, there are no empiric recommendations and few resources promoting regular exercise during the chronic stroke period.Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
Read the detailed description
Stroke is a major cause of chronic disability worldwide. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. Comorbid cardiovascular conditions are present in 75% of stroke patients, representing the leading cause of death in stroke survivors. Due to the low levels of physical activity, stroke survivors are deconditioned, leading to a loss of functional and social independence with subsequent declines in quality of life. Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
The first aim of the study is to evaluate the effects of a high intensitive physical training in improving cardiorespiratory fitness and gait ability in chronic stroke patients. The second aim is to compare the effects of high aerobic interval treadmill training and maximal strength training in chronic stroke patients.
Patients will be randomized into three groups. The first group (experimental group) will be subjected to 3-month training period (3 sessions/week) of high intensity aerobic training on treadmill. The second group (experimental group group) will undergo to a strength training with the same duration and frequency of the first group. The third group (control group)will be subjected to conventional training with the same duration and frequency of the experimental groups. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed.
As primary outcomes measures will be considered the peak oxygen uptake, walking energy cost, 6 minutes walking test. As secondary outcomes measures will be considered the 10-meter Walking Test,Time Up and Go test, Activities- specific balance confidence scale, SF-36 Health Survey Questionnaire, Stroke Impact Scale, Oxygen Uptake Efficiency Slope (OUES), arterial-venous oxygen difference; cardiac output and muscle strength.
- Conditions
- Stroke
- Being tested
- High intensity aerobic training, High Intensity Strength Training, Mixed Training
- Keywords
- Chronic Stroke, Gait, Exercise, High intensity aerobic training, Strength training, Randomized controlled trial
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity aerobic trainingOther
The mode of the training will be uphill treadmill walking in 4x4 minute intervals at 85% and 95% of Heart Rate Peak (HRpeak) precede by 10-minute warm-up period on the treadmill at self-selected speed and inclination. Between the 4-minute intervals, 3-minute active breaks walking at approximately 50% of HRpeak will be applied. The training sessions will be terminated by a 3-minute cool-down period at 50% to 70% HRpeak. To compensate for increased VO2peak, the speed and/or inclination will be gradually adjusted during 3-month intervention to make sure that the target HR will be between 85% and 95% of HRpeak during the high-intensity intervals.
High Intensity Strength TrainingOther
Five warm-up repetitions will be completed at approximately 50% of 1 repetition maximum before the main session of four sets of four repetitions unilaterally at 85%Y95% of 1 repetition maximum for both leg press and plantarflexion. When subjects will be able to complete a fifth repetition, the weight will be increased by 1.25 to 2.5 kg, dependent on subjective feelings of capability. They will be encouraged to focus of an explosive concentric movement and a controlled eccentric movement such that the time on each phase will be in the ratio 1:2. The subjects will be regularly reminded to focus on breathing during the contraction, preventing the valsalva maneuver and high rises in blood pressure. The session will finish with a minimum 5-min warm down the treadmill device.
Mixed TrainingOther
Also called Conventional Training
Conventional training consisted of group mobility, balance and stretching exercises. Mobility training included treadmill and cycloergometer training for 10 minutes at self selected speed. Exercises at the parallel bars included weight shift from leg to leg, half-squat, turn in place, leg-trunk flexion, and extension exercises. Finally seated upper- and lower-limb stretching exercises will focus on range of motion, including trunk mobility.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Aerobic training | Experimental | The subjects will perform a high intensity treadmill training Receives: Other: High intensity aerobic training |
| High Intensity Strength Training | Experimental | The subjects will perform and high intensity training on the same leg horizontal press. Receives: Other: High Intensity Strength Training |
| Mixed Training | Active comparator | Conventional training consisted of group mobility, balance and stretching exercises. Receives: Other: Mixed Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test (6-MWT)
this is a validated tool evaluating walking capacity. Subjects will be required to walk at their maximum speed for 6 minutes and the score will be the covered distance.
Measured: All patients enrolled in the study will be evaluated at baseline time 0 of treatment and after after 12 weeks of training.
Secondary outcomes (12)
10 meters Walking test (10-MtWT)
the test has been selected as a measure of gait speed. This is a validated test requiring individuals to walk on a flat hard floor at their fastest speed foe 10 meters. Scoring is walking speed.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Time Up and Go Test (TUG)
this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Gait analysis
It is an electronic system used for the gathering of the temporal-spatial data of deambulation. It is made up of an 8 meter long sensorized walkway connected to a computer. The system records the signal, reproducing the pressure maps of each step on video, identifying the progression of the center of gravity and recording all of the temporal-spatial features of gait.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Strength
Cybex 6000 isokinetic dynamometer: the system will be used to assess the strength of knee flexors/extensors, and ankle dorsiflexors/plantarflexors bilaterally.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Arterial - venous oxygen difference (a-v O2 diff)
NEAR INFRARED SPECTROSCOPY (NIRS), an 8-channel continuous wave NIRS to monitor LMO2 and blood volume (LMBV) during maximal incremental exercise will be used during the incremental treadmill test. Muscle oxygenation will be determinate by subtracting the absorbencies at 730 and 850 nm, which will give the relative change in the oxy/de-oxy hemoglobin/myoglobin. Furthermore, the sum of absorbencies at these 2 wavelengths will give the change in local blood volume that is attributed to change in total hemoglobin. The NIRS probe will be placed over the vastus lateralis of the both legs, approximately 120 to 140 mm above the knee, along the vertical axis of the thigh. The NIRS signal will be collected at rest and during exercise at a sampling frequency of 3 Hertz, and the data will be averaged over 30 seconds.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Cardiac Output (CO)
cardiac output will be measured during incremental treadmill test using a non- invasive method by "Portapres". This tool derives continuous estimates of cardiac output from the peripheral pulse, the cuff will be fitted to the middle finger of the health hand.
Measured: Basline, Post- training, Follow- up 6 and 9 months
Oxygen Uptake Efficiency Slope (OUES)
provides an estimation of the efficiency of ventilation with respect to VO2, with greater slopes indicating greater ventilatory efficiency. When VO2 in mL/min is plotted on the y axis and VE in L/min is plotted on the "semilog" transformed x axis, the slope of this linear relationship, "a" represents the rate of increase in VO2 in response to VE and is defined as OUES, whereas "b" is the intercept.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Activities- specific Balance Confidence Scale:
this is a scale in which the subject rated his/her perceived level of confidence while performing 16 daily activities. The score ranges from 0 to 100, where 100 represents a high level of confidence in balance skills
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
SF-36 Health Survey Questionnaire
this is a multi- purpose, short form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and preference-based health index. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Stroke Impact scale
this 64-item questionnaire is self- administered, with each item scored on a 5-point Likert scale, and assesses 8 domains of stroke.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Peak of Oxygen Consumption (VO2peak)
a Quark gas analysis system will be used to measure the percentage of expire oxygen. The system will be calibrated before each session according to the manufacturer's instructions. Heart rate will be measured using a Polar Heart-rate monitor. The test will be initiated asking the subject to stand at rest for a period of one minute. At the end of this period the test starts and the subject will walk at its self- selected (obtained by 6MWT) at the inclination of 1%. After three minutes the treadmill inclination will be increased by 1% every minute until exhaustion.
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Walking energy cost (Wc)
the test will be initiated asking the subjects to sit at rest for a period of two minutes. At the end of this period the test commenced. Subject will walk on the treadmill performing three 4-minute steps. The speed of each step will be determinate by the self-selected speed of the subject (obtained through 6MWT). The steps will be 70% of the self- selected speed, 100% and 130%. Throughout the test, ventilatory parameters and heart rate will be collected breath-by-breath using a Quark gas analysis system. The walking energy cost will be calculated according to the formula (O2cost= [VO2/kg walking - VO2/kg rest]/speed).
Measured: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
- Investigators
- Nicola Smania, Physician, Principal investigator, Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777113
- Sponsor's protocol ID
- HIGHSTROKE-2012
- Status last verified
- Sep 2016
- First submitted
- 3 Jan 2013
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a High Intensity Gait Training in Improving Oxygen Consumption in Chronic Stroke Patients: a Randomized Control Study.
- ClinicalTrials.gov ID
- NCT01777113
- Acronym / sponsor ID
- HIGHSTROKE-2012
- Conditions
- Stroke
- Keywords
- Chronic Stroke, Gait, Exercise, High intensity aerobic training, Strength training, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Jan 2013 (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.
Stroke is a global health-care problem that is common, serious and disabling. In most countries, stroke is second or third most common cause of death and one of the main causes of acquired adult disability. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. After completion of conventional physical therapy, there are no empiric recommendations and few resources promoting regular exercise during the chronic stroke period.Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
Detailed description
Stroke is a major cause of chronic disability worldwide. After stroke, patients remain at continued high risk for recurrent stroke as well as for myocardial infarction and cardiac death. Comorbid cardiovascular conditions are present in 75% of stroke patients, representing the leading cause of death in stroke survivors. Due to the low levels of physical activity, stroke survivors are deconditioned, leading to a loss of functional and social independence with subsequent declines in quality of life. Interventions to improve cardiorespiratory fitness are still not part of routine neurorehabilitation programs in many rehabilitation centers, and therapy is often dominated by standard rehabilitative therapies based on neurodevelopmental principles such as the Bobath concept. These standard therapies are an insufficient stimulus to increase fitness levels after stroke.
The first aim of the study is to evaluate the effects of a high intensitive physical training in improving cardiorespiratory fitness and gait ability in chronic stroke patients. The second aim is to compare the effects of high aerobic interval treadmill training and maximal strength training in chronic stroke patients.
Patients will be randomized into three groups. The first group (experimental group) will be subjected to 3-month training period (3 sessions/week) of high intensity aerobic training on treadmill. The second group (experimental group group) will undergo to a strength training with the same duration and frequency of the first group. The third group (control group)will be subjected to conventional training with the same duration and frequency of the experimental groups. Data will be analysed by means parametric and non-parametric tests. Both, within and between groups comparison will be performed.
As primary outcomes measures will be considered the peak oxygen uptake, walking energy cost, 6 minutes walking test. As secondary outcomes measures will be considered the 10-meter Walking Test,Time Up and Go test, Activities- specific balance confidence scale, SF-36 Health Survey Questionnaire, Stroke Impact Scale, Oxygen Uptake Efficiency Slope (OUES), arterial-venous oxygen difference; cardiac output and muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Aerobic training | Experimental | Other: High intensity aerobic trainingThe subjects will perform a high intensity treadmill training |
| High Intensity Strength Training | Experimental | Other: High Intensity Strength TrainingThe subjects will perform and high intensity training on the same leg horizontal press. |
| Mixed Training | Active comparator | Other: Mixed TrainingConventional training consisted of group mobility, balance and stretching exercises. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of ischemical brain injury or intracerebral hemorrhage by MRI or computed tomography at least 6 months before the onset of the study;
- Ability to walk in the treadmill at >0.3 km/h for 3 minutes handrail support;
- Be able to give informed consent and be motivated to participate in 3- month intensive physical fitness training.
Key exclusion criteria (7 listed)
- Mini Mental State Examination <20;
- Unstable angina pectoris;
- Unstable cardiac conditions;
- Complex ventricular arrhythmia;
- Resting systolic blood pressure >200 mm/Hg - Resting diastolic blood pressure >100 mm/Hg;
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 |
|---|---|---|
| High intensity aerobic trainingThe mode of the training will be uphill treadmill walking in 4x4 minute intervals at 85% and 95% of Heart Rate Peak (HRpeak) precede by 10-minute warm-up period on the treadmill at self-selected speed and inclination. Between the 4-minute intervals, 3-minute active breaks walking at approximately 50% of HRpeak will be applied. The training sessions will be terminated by a 3-minute cool-down period at 50% to 70% HRpeak. To compensate for increased VO2peak, the speed and/or inclination will be gradually adjusted during 3-month intervention to make sure that the target HR will be between 85% and 95% of HRpeak during the high-intensity intervals. | Other | High Intensity Aerobic training |
| High Intensity Strength TrainingFive warm-up repetitions will be completed at approximately 50% of 1 repetition maximum before the main session of four sets of four repetitions unilaterally at 85%Y95% of 1 repetition maximum for both leg press and plantarflexion. When subjects will be able to complete a fifth repetition, the weight will be increased by 1.25 to 2.5 kg, dependent on subjective feelings of capability. They will be encouraged to focus of an explosive concentric movement and a controlled eccentric movement such that the time on each phase will be in the ratio 1:2. The subjects will be regularly reminded to focus on breathing during the contraction, preventing the valsalva maneuver and high rises in blood pressure. The session will finish with a minimum 5-min warm down the treadmill device. | Other | High Intensity Strength Training |
| Mixed TrainingAlso: Conventional TrainingConventional training consisted of group mobility, balance and stretching exercises. Mobility training included treadmill and cycloergometer training for 10 minutes at self selected speed. Exercises at the parallel bars included weight shift from leg to leg, half-squat, turn in place, leg-trunk flexion, and extension exercises. Finally seated upper- and lower-limb stretching exercises will focus on range of motion, including trunk mobility. | Other | Mixed Training |
Primary outcome
6 minutes walking test (6-MWT)
Time frame: All patients enrolled in the study will be evaluated at baseline time 0 of treatment and after after 12 weeks of training.
this is a validated tool evaluating walking capacity. Subjects will be required to walk at their maximum speed for 6 minutes and the score will be the covered distance.
12 secondary outcomes
10 meters Walking test (10-MtWT)
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Time Up and Go Test (TUG)
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Gait analysis
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Strength
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Arterial - venous oxygen difference (a-v O2 diff)
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Cardiac Output (CO)
Time frame: Basline, Post- training, Follow- up 6 and 9 months
Oxygen Uptake Efficiency Slope (OUES)
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Activities- specific Balance Confidence Scale:
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
SF-36 Health Survey Questionnaire
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Stroke Impact scale
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Peak of Oxygen Consumption (VO2peak)
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Walking energy cost (Wc)
Time frame: Baseline time 0, after 12 weeks of training, after 6 months 6 and 9 months after the end of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Nicola Smania, Physician principal investigator
Neuromotor and Cognitive Rehabilitation Center Department of Neurological, Neuropsychological, Morfological and Motor Sciences University of Verona, Verona, Italy
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 intensity aerobic training, High Intensity Strength Training and Mixed Training in people with Stroke, run by Universita di Verona at 2 sites in Italy.
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 7 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 12 Sep 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Smania, Physician (+39 045 8124573, nicola.smania@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (6-MWT) (time frame: All patients enrolled in the study will be evaluated at baseline time 0 of treatment and after after 12 weeks of training.). 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 12 Sep 2016.