DiabetesNCT01393275
Effects of Exercise Intervention and Rehabilitation Exercise Intervention in Patients With Type 2 Diabetes
A study testing rehabilitation exercise intervention in people with Diabetes and Diabetes Mellitus, Non-Insulin-Dependent, run by University of Giessen at 2 sites in Germany.
Trial summary
The purposes of the study are to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- rehabilitation exercise intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2010to Oct 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 diabetes (ADA criteria)
- admitted diabetes treatment will be diet and oral hypoglycemic agents
Who cannot join
- sports intervention > 60 minutes per week
- medical conditions
- proliferative retinopathy
- instable coronary heart disease
- acute clinically significant intercurrent disease
- inability to perform scheduled physical activity programs
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Giessen
Giessen, Hesse, 35394
Sportpark Zwickau, Glauchau, Meerane
Zwickau, Saxony, 08056
About this study
Official title: Effects of Exercise Intervention in Patients With Type 2 Diabetes - Strength Endurance Exercise Intervention Versus Combination of Strength Endurance Exercise Intervention and Rehabilitation Exercise Intervention
The purposes of the study are
- to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients
- to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective in improving the metabolic parameters in patients with type 2 diabetes
- to assess which exercise intervention induces higher effects to the metabolic rate and cardiac and pulmonary capacity
- to investigate what kind of intervention includes highest effects in long term persistence of these positive effects
- Conditions
- Diabetes, Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- rehabilitation exercise intervention, placebo control group
- Keywords
- diabetes, exercise, intervention, rehabilitation, metabolic rate, sport
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation exercise interventionOther
exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 60 minutes rehabilitation exercise training - once a week
15 minutes warm up, 30 minutes strength endurance training - once a week
placebo control groupOther
exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 5 minutes walking 55 minutes conversation in the group- once a week
15 minutes warm up, 30 minutes strength endurance training - once a week
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation intervention group | Active comparator | The group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention. Receives: Other: rehabilitation exercise intervention |
| Placebo rehabilitation | Placebo comparator | The group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention. Receives: Other: placebo control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
alteration of HbA1c-level (haemoglobin A1c)
Measured: 6 months
Secondary outcomes (12)
alteration of total cholesterol level
Measured: 6 months
alteration of LDL-cholesterol-level
Measured: 6 months
alteration of HDL-cholesterol-level
Measured: 6 months
alteration of triglyceride-level
Measured: 6 months
alteration of antidiabetic medications
Measured: 6 months
alteration of anthropometry
body weight; body mass index; hip-to-waist-ratio
Measured: 6 months
alteration of body composition
measured by Bio-impedance analysis
Measured: 6 months
alteration of resting metabolic rate
- measured by Spirometrie (Cortex metamax)
- calculated by Bio-impedance analysis (TANITA)
Measured: 6 months
alteration of blood pressure
Measured: 6 months
alteration of cardiac and pulmonary capacity
- measured by ergometry
- six-minutes walk test
Measured: 6 months
alteration of quality of life
Measured: 6 months
follow up of all parameters mentioned above
follow up after 15 months without any supervised intervention
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Sportpark Zwickau, Germany, Sportpark Glauchau, Germany, Comenius University
- Responsible party
- Principal investigator, Andree Hillebrecht, University of Giessen
- Investigators
- Andree Hillebrecht, Dr. med., Study chair, University of GiessenDusan Hamar, Prof. Dr., Study director, Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393275
- Sponsor's protocol ID
- Gi-01-2010
- Status last verified
- Nov 2011
- First submitted
- 12 Jul 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Intervention in Patients With Type 2 Diabetes - Strength Endurance Exercise Intervention Versus Combination of Strength Endurance Exercise Intervention and Rehabilitation Exercise Intervention
- ClinicalTrials.gov ID
- NCT01393275
- Acronym / sponsor ID
- Gi-01-2010
- Conditions
- Diabetes, Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- diabetes, exercise, intervention, rehabilitation, metabolic rate, sport
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Sportpark Zwickau, Germany, Sportpark Glauchau, Germany, Comenius University
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Jul 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 purposes of the study are
- to determine if a supervised exercise intervention is improving the metabolic parameters in type 2 diabetes patients
- to investigate what kind of intervention (strength endurance training versus combined strength endurance training and rehabilitation exercise intervention)is more effective in improving the metabolic parameters in patients with type 2 diabetes
- to assess which exercise intervention induces higher effects to the metabolic rate and cardiac and pulmonary capacity
- to investigate what kind of intervention includes highest effects in long term persistence of these positive effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation intervention group | Active comparator | Other: rehabilitation exercise interventionThe group is performing a strength endurance training intervention in addition with rehabilitation exercise intervention. |
| Placebo rehabilitation | Placebo comparator | Other: placebo control groupThe group is performing a strength endurance training intervention in addition with placebo rehabilitation exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of type 2 diabetes (ADA criteria)
- admitted diabetes treatment will be diet and oral hypoglycemic agents
Key exclusion criteria (6 listed)
- sports intervention > 60 minutes per week
- medical conditions
- proliferative retinopathy
- instable coronary heart disease
- acute clinically significant intercurrent disease
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 |
|---|---|---|
| rehabilitation exercise interventionexercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 60 minutes rehabilitation exercise training - once a week 15 minutes warm up, 30 minutes strength endurance training - once a week | Other | Rehabilitation intervention group |
| placebo control groupexercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 5 minutes walking 55 minutes conversation in the group- once a week 15 minutes warm up, 30 minutes strength endurance training - once a week | Other | Placebo rehabilitation |
Primary outcome
alteration of HbA1c-level (haemoglobin A1c)
Time frame: 6 months
12 secondary outcomes
alteration of total cholesterol level
Time frame: 6 months
alteration of LDL-cholesterol-level
Time frame: 6 months
alteration of HDL-cholesterol-level
Time frame: 6 months
alteration of triglyceride-level
Time frame: 6 months
alteration of antidiabetic medications
Time frame: 6 months
alteration of anthropometry
Time frame: 6 months
alteration of body composition
Time frame: 6 months
alteration of resting metabolic rate
Time frame: 6 months
alteration of blood pressure
Time frame: 6 months
alteration of cardiac and pulmonary capacity
Time frame: 6 months
alteration of quality of life
Time frame: 6 months
follow up of all parameters mentioned above
Time frame: 15 months
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 8 Nov 2011.
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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.
Andree Hillebrecht, Dr. med. study chair
University of Giessen
Dusan Hamar, Prof. Dr. study director
Comenius 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 rehabilitation exercise intervention in people with Diabetes and Diabetes Mellitus, Non-Insulin-Dependent, run by University of Giessen at 2 sites 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 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 8 Nov 2011. 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 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. 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.
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?
alteration of HbA1c-level (haemoglobin A1c) (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 8 Nov 2011.