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

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

      • 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.

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.

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