ACTIVE_NOT_RECRUITING

Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial

Quick Facts

Study Start:2020-11-13

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05819333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 95 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Locations (Sites)

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216

United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-13

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2020-11-13

Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

Stroke