NCT04520763

Brief Summary

To evaluate the acute effects of respiratory muscle exercises vs. a control intervention on blood glucose kinetics in healthy adults after an oral glucose tolerance test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

August 17, 2020

Last Update Submit

March 16, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Peak blood glucose concentration

    Peak blood glucose concentration will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).

    throughout the study, an expected average of 2 weeks per participant

  • area under the glucose-time curve

    Area under the glucose-time curve will be determined in the three conditions (5min or 15min respiratory muscle exercises or control).

    throughout the study, an expected average of 2 weeks per participant

Study Arms (2)

Respiratory Muscle Exercises

EXPERIMENTAL

Two respiratory muscle exercises

Other: 5min respiratory muscle exercisesOther: 15min respiratory muscle exercises

Control

NO INTERVENTION

The control intervention consists of quiet sitting for 15 min

Interventions

5 min of hyperpnea at a target intensity of 60-80% MVV 15-30min after ingestion of 75g of glucose

Respiratory Muscle Exercises

5 min of hyperpnea at a target intensity of 60-70% MVV 15-30min after ingestion of 75g of glucose

Respiratory Muscle Exercises

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Healthy
  • Non-smoking
  • Body mass index (BMI): 18.5 - 29.9 kg∙m-2
  • Normal lung function
  • Willing to adhere to study rules

You may not qualify if:

  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Intake of medications affecting metabolism, the cardiovascular or the respiratory system, or sleep
  • Acute illness or chronic conditions of the gastrointestinal tract, and health conditions affecting metabolism, the cardiovascular or the respiratory system, or sleep
  • Pregnancy, breastfeeding, or intention to become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

Zurich, Canton of Zurich, 8057, Switzerland

Location

Study Officials

  • Christin M. Spengler, Prof.

    Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study consists of four visits to the laboratory, each separated by at least 24 hours and each lasting approximately 2.5h. Total duration for each participant is approximately 2 weeks. The study is conducted in 40 healthy adults (≥ 18 years). The study is a randomized, controlled cross-over trial. We chose a cross-over design in order to test the effects of different respiratory exercises compared to a control intervention in order to minimize variability since each subject serves as his/her own control. Due to the nature of the intervention (respiratory muscle exercises), it is not possible to blind participants to the interventions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 20, 2020

Study Start

August 20, 2020

Primary Completion

April 21, 2022

Study Completion

April 21, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations