Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training

NCT05819333 | Active Not Recruiting

• 1 other identifier: 20K08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the hypothesis that combined Respiratory Muscle Training and a Stroke Wellness Program is more effective than a Stroke Wellness Program alone for stroke survivors with and without a smoking exposure history. Participants will participant in a Stroke Wellness Program consisting of strengthening, cardiovascular and flexibility training program plus respiratory exercise for 24 sessions (3x/week for 8 weeks). Researchers will compare outcomes to those randomized to a respiratory strengthening program compared to a relaxation training program to see if those who received respiratory strengthening had improved maximal respiratory pressure, improved physical activity and improved quality of life compared to those who received relaxation training.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Maximum Inspiratory Pressure Change

  Maximum inspiratory pressure achieved in five seconds; min value: 0; max value:100; higher value is better.

  Week 9

Secondary Outcomes (11)

• Maximum Expiratory Pressure Change

  Week 9

• Peak Cough Flow Change

  Week 9

• Forced Vital Capacity (FVC)/Forced Expiratory Volume in one second (FEV1) Change

  Week 9

• Six Minute Walk Test Change

  Week 9

• Five Times Sit to Stand Change

  Week 9

Study Arms (2)

Respiratory Strength Training

EXPERIMENTAL

In addition to the Exercise Program of Flexibility, Strengthening and Cardiovascular training, subjects assigned to the Respiratory Strength Training group will use a threshold training device to resist inspiration and expiration (Orygen Dual Valve, Forumed). The respiratory ports are held closed by adjustable-tension springs, and subjects must overcome the tension to inhale or exhale air from the lung. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest \~1 minute between sets. Inspiratory muscle training (5 sets of 5 breaths) and expiratory muscle training (5 sets of 5 breaths) will be conducted separately. Initial intensity will be 50-70% of the maximal inspiratory and expiratory pressures the subject can generate.

Other: Exercise Program + Respiratory Strength Training

Respiratory Relaxation Training

ACTIVE COMPARATOR

In addition to the Exercise Program of Flexibility, Strengthening and Cardiovascular training, subjects assigned to the Respiratory Relaxation Training group will be issued the Threshold Positive Expiratory Pressure training device modified to partially inactivate the one-way valve to remove resistance. Much like the Respiratory Strength Training device, the RRT device was selected for its simplicity and adaptability. This device has been used in prior controlled studies as a placebo RST device. Subjects will be instructed to breathe slowly through the device, 5 sets of 5 breaths, with \~1 minute of rest between sets. These "5 sets of 5 breaths" will occur twice during the intervention session, one near the beginning of the session and one near the end. While effects of relaxation breathing exercises may include a modest lowering of systolic BP in some hypertensive patients, this group primarily serves as an active control.

Other: Exercise Program + Respiratory Relaxation Training

Interventions

Exercise Program + Respiratory Strength Training OTHER

Strength, Flexibility, Cardiovascular exercise + respiratory strength training

Respiratory Strength Training

Exercise Program + Respiratory Relaxation Training OTHER

Strength, Flexibility, Cardiovascular exercise + respiratory relaxation training

Respiratory Relaxation Training

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke
• Greater than 6 months post-stroke
• Signed letter of medical approval from primary care physician to participate in this research study
• Community dwelling
• Ability to attend the wellness program 3x/week for eight weeks
• Ability to follow instructions or mimic exercises
• Ability to communicate adverse effects such as pain or fatigue or the need for assistance
• Able to ambulate 20 feet with no more than contact guard assist, with or without an assistive device or orthotic device
• Able to access exercise equipment independently or with caregiver assist
• Greater than 18 years of age

You may not qualify if:

• Neurologic condition other than stroke, i.e. Parkinson's Disease, multiple sclerosis
• Severe, functional limiting arthritis
• Orthopedic condition that limits mobility
• Severe weight-bearing pain
• Current participation in other physical rehabilitation services or exercise programs
• Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within the past year, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
• Severe hypertension: with systolic \> 200 mmHg and diastolic \> 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg
• Use of supplemental oxygen at baseline
• Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD)39 3 or higher, indicating FEV1\<50% predicted)
• Treatment for pneumonia or lower respiratory infection within the past month
• Able to run one-quarter mile without stopping

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216, United States

Location

Related Publications (1)

• Rose DK, Brunetti G, Cavka K, Hoisington JB, Snyder H, Xue W, Smith BK. Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 27;13:e59749. doi: 10.2196/59749.

  PMID: 39602207 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked as to whether study participants received Respiratory Muscle Training or Relaxation Training
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 19, 2023
• Study Start: November 13, 2020
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)