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CompletedNCT02313142STAMASUpdated Sep 18, 2019

Responses of the Cardiovascular Systems to Leg Exercises in Microgravity-like Conditions

An interventional study of Leg exercises in Cardiovascular Deconditioning, sponsored by Swiss Federal Institute of Technology. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

One of the major issues in space explorations is the negative effect of prolonged exposure to very low gravity (i.e. a condition often referred to as microgravity or weightlessness) on astronauts' health. In this unusual condition the human body undergoes an adaptation process, often referred to as "deconditioning", that leads to significant loss of bone and muscle mass, hormonal changes, as well as modifications of important cardiovascular parameters. While the new physiological state is adequate to the microgravity environment, it results unsuitable upon return on earth. Hence after the mission astronauts experience various health-related problems and must undertake an intense rehabilitation program. Cardiovascular deconditioning originates mainly from a shift of blood from the lower extremities to the upper part of the body caused by the absence of gravity. In the long term (i.e. days) this causes a loss of blood and body fluid. In the short term (i.e. minutes) it elicits modifications to arterial blood pressure and heart rate.

In this study, funded by the European Union through the project STAMAS, we intend to evaluate whether leg physical exercises can lead to a displacement of blood towards the lower extremities, therefore ameliorating the upward fluid shift caused by weightlessness. More generally, we aim to investigate the short-term response of the cardiovascular system to leg exercises in microgravity-like conditions. After a clear understanding of these phenomena we will develop a controller that, by monitoring the physiological stare of a subject, will compute the appropriate exercise regime to stabilize his/her cardiovascular parameters to desired safe values. Our contribution will provide a better understanding of the cardiovascular system, and will delineate the physiological ground for the development of novel countermeasure devices against the cardiovascular deconditioning during space flight based on continuous leg exercises.

The protocol we propose in this document presents minimal risks for our potential subjects, while has the potential to produce important contributions. The cardiovascular parameters we intend to analyse are: blood pressure, heart rate and leg blood volume. These signals will be acquired non-invasively and with minimal risks. Leg exercises will be performed by means of a stepping device (MARCOS) previously developed in our Lab. MARCOS enables to vary the resistance applied against knee-extension movements, and therefore it allows a systematic evaluation of different exercise intensities. Finally, microgravity conditions can be easily emulated by letting the subjects lay on a tilted platform with head-down (i.e. head-down bed rest - HDBR, or head-down tilt - HDT) during the exercise sessions, thus inducing a shift of body fluid toward the thorax. The most effective inclination angle has proved to be as low as -6°, thus constituting only minimal risks for the subjects. In practice, subjects will comfortably lay on the negatively tilted platform and will perform stepping at different intensities while their cardiovascular parameters are being monitored and recorded in encrypted form for subsequent analysis.

02

Conditions studied

  • Cardiovascular Deconditioning
03

In context

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Fracture lower extremities
  • Restricted range of motion in hip, knee or ankle joint which restricts standing or walking
  • Any injury limiting movements of the lower extremities
  • Pregnancy
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc
  • Presence of any psychiatric condition
  • Tachycardia
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Subjects

    Behavioral: Leg exercises

Interventions

  • BehavioralLeg exercises
06

What researchers measure

Primary outcomes

  1. Leg blood volume

    Time frame: 110 min

Secondary outcomes

  1. Heart-rate

    Time frame: 110 min

  2. Blood pressure

    Time frame: 110 min

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02313142
Lead sponsor
Swiss Federal Institute of Technology
Responsible party
Verena Klamroth (MD, Swiss Federal Institute of Technology) — Principal investigator
First posted
Dec 9, 2014
Start date
Jan 2015
Primary completion
Dec 2015
Last update
Sep 18, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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