Healthy VolunteersNCT02951494
Impact of Lower Body Weight Support Treadmill on Cardiopulmonary Exercise Capacity and Trainability
A study testing AlterG Anti-gravity treadmill in people with Healthy Volunteers, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AlterG Anti-gravity treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to 31 Dec 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- maximal oxygen consumption below age-sex specific standard
Who cannot join
- 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
Show all 16Show fewer
- congenital heart disease
- cardiomyopathy
- severe left ventricular hypertrophy
- cardiac arrythmias
- hypertension
- diabetes
- BMI > 35
- cancer
- pregnancy
- aneurysm of aorta or cerebral arteries
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardiovascular examination center of the University Medicine Greifswald
Greifswald, 17489
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- AlterG Anti-gravity treadmill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlterG Anti-gravity treadmillOther
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
| Study group | Role | What they receive |
|---|---|---|
| AlterG Anti-gravity treadmill | Active comparator | cont. aerobic exercise training with lower body weight support Receives: Other: AlterG Anti-gravity treadmill |
| Exercise without body weight support | No intervention | cont. aerobic exercise training without lower body weight support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption
VO2peak [ml/min]
Measured: 12 weeks
Secondary outcomes (2)
Oxygen consumption at anaerobic threshold
VO2@AT
Measured: 12 weeks
Pulse wave velocity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Dörr, M.D., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951494
- Sponsor's protocol ID
- AlterG-Training-I Studie
- Status last verified
- Sep 2021
- First submitted
- 12 Oct 2016
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Brussau T, Oehring R, Felix SB, Dorr M, Bahls M. Cardiorespiratory and metabolic responses to exercise testing during lower-body positive pressure running. J Appl Physiol (1985). 2020 Apr 1;128(4):778-784. doi: 10.1152/japplphysiol.00328.2019. Epub 2020 Feb 13.
PubMed 32053417
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Der Körpergewichtsunterstützung Auf Einem AlterG®-Antigravitationslaufband Auf Die Kardiopulmonale Leistungsfähigkeit Und Trainierbarkeit
- ClinicalTrials.gov ID
- NCT02951494
- Acronym / sponsor ID
- AlterG-Training-I Studie
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Nov 2016 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlterG Anti-gravity treadmill | Active comparator | Other: AlterG Anti-gravity treadmillcont. aerobic exercise training with lower body weight support |
| Exercise without body weight support | No intervention | –cont. aerobic exercise training without lower body weight support |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- maximal oxygen consumption below age-sex specific standard
Key exclusion criteria (16 listed)
- 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)
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 |
|---|---|---|
| AlterG Anti-gravity treadmillParticipants in this group will complete a 12 week aerobic exercise training protocol with 40% lower body weight support on an AlterG Anti-gravity treadmill | Other | AlterG Anti-gravity treadmill |
Primary outcome
Maximal oxygen consumption
Time frame: 12 weeks
VO2peak [ml/min]
2 secondary outcomes
Oxygen consumption at anaerobic threshold
Time frame: 12 weeks
Pulse wave velocity
Time frame: 12 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 25 May 2022.
- Derived from this study: PubMed 32053417Brussau T, Oehring R, Felix SB, Dorr M, Bahls M. Cardiorespiratory and metabolic responses to exercise testing during lower-body positive pressure running. J Appl Physiol (1985). 2020 Apr 1;128(4):778-784. doi: 10.1152/japplphysiol.00328.2019. Epub 2020 Feb 13.
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Screening Protocol
Pain
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.
Marcus Dörr, M.D. principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlterG Anti-gravity treadmill in people with Healthy Volunteers, run by University Medicine Greifswald 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 1 inclusion and 16 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 25 May 2022. 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?
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?
Maximal oxygen consumption (time frame: 12 weeks). 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 NCT02951494, 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 25 May 2022.