Exercise TrainingNCT03208751
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
A study testing Exercise training in people with Exercise Training and Coronary Artery Disease, run by Technical University of Munich at 1 site in Germany.
Trial summary
Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Exercise Training, Coronary Artery Disease, Diabetes Mellitus, Type 2
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2011to 1 Jan 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease and/or diabetes mellitus
- Heart failure
Who cannot join
- all conditions which are not compatible with exercise training:
- severe orthopedic disorders
- severe psychiatric disease
- severe valve insufficiency
- presence of myocardial ischemia (decision made by cardiologist)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar/ Technische Universitaet Muenchen
Munich, 81675
About this study
Official title: A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting
Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.
Read the detailed description
From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.
- Being tested
- Exercise training
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Exercise intervention was divided into 3 phases:
Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14).
Nutritional counseling is offered up to 4 times in 6 months on an individual basis.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Other | All patients were included in the exercise training group Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2peak in ml/kg/min
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
Measured: 6 months
Secondary outcomes (11)
Change in HbA1c for patients with diabetes
Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus
Measured: 6 months
Change in hsCRP
high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
Measured: 6 months
Change in E/e'
E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal
Measured: 6 months
Change in quality of life measured by SF-36
The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
Measured: 6 months
Change in insulin IU
Insulin dosage is measured in IE (international units)
Measured: 6 months
Change in HDL- and LDL- cholesterol as well as triglycerides
all measured in mg/dl
Measured: 6 months
Change in Adiponectin
Adiponectin is an adipokine which is released by fat tissue
Measured: 6 months
Change in Watts at anaerobic threshold VAT
VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
Measured: 6 months
Change in Watts at anaerobic threshold RCP
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
Measured: 6 months
Change in max. Watts
On bicycle ergometry, Watts are measured
Measured: 6 months
Change in max. Watts/kg bodyweight
max. Watts indexed b body weight
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Apr 2011
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm intervention with exercise training as secondary prevention strategy
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey W Christle, Technical University of Munich
- Investigators
- Martin Halle, Prof., Study director, Technical University Munic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208751
- Sponsor's protocol ID
- 5132/11
- Status last verified
- Jul 2019
- First submitted
- 26 May 2017
- Last updated
- 19 Jul 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 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting
- ClinicalTrials.gov ID
- NCT03208751
- Acronym / sponsor ID
- 5132/11
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Apr 2011 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 6 Jul 2017 (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.
Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.
Detailed description
From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm intervention with exercise training as secondary prevention strategy
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Other | Behavioral: Exercise trainingAll patients were included in the exercise training group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary artery disease and/or diabetes mellitus
- Heart failure
Key exclusion criteria (5 listed)
- all conditions which are not compatible with exercise training:
- severe orthopedic disorders
- severe psychiatric disease
- severe valve insufficiency
- presence of myocardial ischemia (decision made by cardiologist)
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 trainingExercise intervention was divided into 3 phases: Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14). Nutritional counseling is offered up to 4 times in 6 months on an individual basis. | Behavioural | Exercise training |
Primary outcome
Change in VO2peak in ml/kg/min
Time frame: 6 months
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
11 secondary outcomes
Change in HbA1c for patients with diabetes
Time frame: 6 months
Change in hsCRP
Time frame: 6 months
Change in E/e'
Time frame: 6 months
Change in quality of life measured by SF-36
Time frame: 6 months
Change in insulin IU
Time frame: 6 months
Change in HDL- and LDL- cholesterol as well as triglycerides
Time frame: 6 months
Change in Adiponectin
Time frame: 6 months
Change in Watts at anaerobic threshold VAT
Time frame: 6 months
Change in Watts at anaerobic threshold RCP
Time frame: 6 months
Change in max. Watts
Time frame: 6 months
Change in max. Watts/kg bodyweight
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Halle, Prof. study director
Technical University Munic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Exercise Training and Coronary Artery Disease, run by Technical University of Munich at 1 site in Germany.
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 2 inclusion and 5 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 19 Jul 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 Germany. 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?
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?
Change in VO2peak in ml/kg/min (time frame: 6 months). 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 19 Jul 2019.