Inspiratory Muscle Strength Training in Adults With Obesity

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFlorida State University

About this trial

The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Not weight stable (<5% change in body mass over the past six months)

Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)

Current, or history of uncontrolled, Stage 2 hypertension (blood pressure >140 / 90 mmHg; anti-hypertensive medications are permitted)

Diagnosed obstructive sleep apnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-resistance inspiratory muscle strength training

    Device

    Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.

  • Very-low-resistance inspiratory muscle strength training

    Device

    Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: High-resistance inspiratory muscle strength trainingActive comparator 1 intervention
Group B: Very-low resistance inspiratory muscle strength trainingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in laboratory-measured blood pressure

Systolic and diastolic blood pressure measured in the laboratory

Time frame
Up to 16 weeks

Secondary outcomes

1

Change in ambulatory blood pressure

Systolic and diastolic blood pressure measured at home using an automated monitor

Time frame
Up to 16 weeks
2

Change in inspiratory muscle strength

Peak inspiratory pressure measured in the laboratory

Time frame
Up to 16 weeks
3

Change in blood pressure reactivity during aerobic exercise

Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test

Time frame
Up to 16 weeks
4

Blood pressure during respiratory muscle testing

Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)

Time frame
Up to 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator