Inspiratory Muscle Strength Training in Chronic Kidney Disease

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04911491
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMST — DEVICE
    Inspiratory muscle strength training (IMST) is a form of physical training that utilizes the diaphragm and accessory respiratory muscles to repeatedly inhale against resistance using a handheld device.
  • Sham Training — DEVICE
    Repeated inhalations against a low resistance will be performed using a handheld device.

Study Details

More than 80% of individuals with chronic kidney disease have concomitant hypertension and the majority fail to achieve blood pressure control \<130/80 mmHg, leading to high risk of cardiovascular diseases and end-stage kidney disease. A stepwise combination of lifestyle modifications and drug therapy is recommended to lower blood pressure; however, adherence to time-intensive lifestyle interventions such as aerobic exercise in patients with chronic kidney disease is poor. This clinical trial seeks to establish the efficacy of high-resistance inspiratory muscle strength training, a novel time-efficient lifestyle intervention, for lowering systolic blood pressure and improving endothelial function in midlife and older adults with moderate-to-severe chronic kidney disease and inadequately controlled hypertension, and to use innovate translational assessments to understand the mechanisms involved.

Key Dates

Start date
Mar 1, 2022
Status verified
Apr 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMST
    This group will perform high-resistance (75% of maximal inspiratory pressure) inspiratory muscle strength training (IMST), 30 inhalations/session, 6 days/week.
  • Sham Comparator: Control
    This group will perform low-resistance (15% of maximal inspiratory pressure) inspiratory muscle strength training, 30 inhalations/session, 6 days/week.

Primary Outcome Measure

Change in Casual Systolic Blood Pressure [ Time Frame: Baseline, 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado - Anschutz Medical CampusAuroraColorado80045
Kristen Nowak, PhD, MPH
[email protected]
303-724-4842
Emily Andrews
[email protected]
303-724-7790
Kristen Nowak, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Michel Chonchol, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Colorado - Anschutz Medical Campus· Aurora, CO

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