NCT02951494

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 25, 2022

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

October 12, 2016

Last Update Submit

May 18, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen consumption

    VO2peak \[ml/min\]

    12 weeks

Secondary Outcomes (2)

  • Oxygen consumption at anaerobic threshold

    12 weeks

  • Pulse wave velocity

    12 weeks

Study Arms (2)

AlterG Anti-gravity treadmill

ACTIVE COMPARATOR

cont. aerobic exercise training with lower body weight support

Other: AlterG Anti-gravity treadmill

Exercise without body weight support

NO INTERVENTION

cont. aerobic exercise training without lower body weight support

Interventions

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

AlterG Anti-gravity treadmill

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • maximal oxygen consumption below age-sex specific standard

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular examination center of the University Medicine Greifswald

Greifswald, 17489, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32053417DERIVED

Study Officials

  • Marcus Dörr, M.D.

    University Medicine Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

November 1, 2016

Study Start

January 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 25, 2022

Record last verified: 2021-09

Locations

DE(1)