- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02951494
Impact of Lower Body Weight Support Treadmill on Cardiopulmonary Exercise Capacity and Trainability
May 18, 2022 updated by: University Medicine Greifswald
Einfluss Der Körpergewichtsunterstützung Auf Einem AlterG®-Antigravitationslaufband Auf Die Kardiopulmonale Leistungsfähigkeit Und Trainierbarkeit
The AlterG®-anti-gravity treadmill provides lower body weight support which enables individuals to exercise without feeling their full body weight.
How this body weight support influences cardiovascular, respiratory, vascular and metabolic parameters is currently unclear.
Further, whether body weight support influences the trainability in response to moderate continuous exercise is unknown.
This investigation has two main goals.
First, we explore the direct influence of lower body weight support on cardiometabolic parameters during maximal exercise testing.
Second, we aim to compare changes in cardiorespiratory fitness in response to a structured exercise protocol using moderate intensity with and without lower body weight support.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Greifswald, Germany, 17489
- Cardiovascular examination center of the University Medicine Greifswald
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- maximal oxygen consumption below age-sex specific standard
Exclusion Criteria:
- acute infection within the last four weeks
- anemia (males: Hb < 8.1 mmol/L; females Hb < 7.4 mmol/L)
- previous reports of myo-, endo, or pericarditis
- previous stroke or acute myocardial infarction
- heart failure (NYHA > 1)
- aortic valve stenosis
- congenital heart disease
- cardiomyopathy
- severe left ventricular hypertrophy
- cardiac arrythmias
- hypertension
- diabetes
- BMI > 35
- cancer
- pregnancy
- aneurysm of aorta or cerebral arteries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: AlterG Anti-gravity treadmill
cont.
aerobic exercise training with lower body weight support
|
Participants in this group will complete a 12 week aerobic exercise training protocol with 40% lower body weight support on an AlterG Anti-gravity treadmill
|
|
NO_INTERVENTION: Exercise without body weight support
cont.
aerobic exercise training without lower body weight support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal oxygen consumption
Time Frame: 12 weeks
|
VO2peak [ml/min]
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen consumption at anaerobic threshold
Time Frame: 12 weeks
|
VO2@AT
|
12 weeks
|
|
Pulse wave velocity
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcus Dörr, M.D., University Medicine Greifswald
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
December 31, 2021
Study Completion (ACTUAL)
December 31, 2021
Study Registration Dates
First Submitted
October 12, 2016
First Submitted That Met QC Criteria
October 28, 2016
First Posted (ESTIMATE)
November 1, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- AlterG-Training-I Studie
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.