Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective RCT.
NCT ID: NCT02614001
Last Updated: 2015-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2011-05-31
2015-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Design: A single-blind prospective randomized controlled study. Setting: A tertiary care medical center. Participant and method A total of twenty stroke patients with stable CHF, class I-III \[NYHA (New York Heart Association)\], aging between 20 to 85 year-old, will be eligible and randomly assigned into IMT and control group. Stroke will be confirmed by computerized tomography or magnetic resonance imaging. And CHF will be confirmed by a cardiologist. Both of groups will receive a conventional stroke rehabilitation program and diaphragmatic breathing training. The IMT groups will be trained daily, 30 minutes per day, at least 5 times a week, for 4 weeks; then readmitted to hospital 2 weeks later. For checking the compliance of IMT at home, patients will be monitored by making a phone call to them twice a week. Or patient will receive an out patient program about 10 weeks if they are not admitted to our hospital.
Main outcome measurement:
Each subject's baseline characteristics, and duration of the disease, neurological level (Brunnstrom's stage), functional level, spirometry; resting heart rate, blood pressure, resting oxyhemoglobin saturation (SpO2), lowest resting SpO2, maximal inspiratory pressure, maximal expiratory pressure, the resting oxyhemoglobin saturation (SpO2), lowest resting SpO2 and Borg's scale during a 6-minute walking test , handgrip strength, visual analog scale for severity of fatigue, fatigue assessment scale, Barthel scale will be assessed before and after program.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Both of groups will receive a conventional stroke rehabilitation program. Exclusion criteria Patients who can't tightly place their lips over the mouthpiece or have air leakage during inhaling or exhaling through the threshold device, have COPD, a history of recent exacerbation, unstable angina, decompensated CHF, complicated arrhythmias, at risk or history of pneumothorax, large bullae on chest radiograph, marked osteoporosis together with a history of spontaneous rib fractures, a history of recent lung surgery (ie, within 12 months), or use of long-term oxygen therapy.
The Institutional Review Board of Chang Gung Memorial Hospital, Kaohsiung Medical Center will approve the study protocol and all patients provided informed consent.
IMT training: Inspiratory muscle training will be performed by using a pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA). During training, patients will be in a sitting position with a nose-clip and instructed to place their lips around the mouthpiece, inhale with enough force to open the valve, exhale through the mouthpiece, and then continue inhaling and exhaling without removing the device from their mouth. During the initial training session, patients will be encouraged to start at a resistance equal to 30% of their MIP or at a load the patient can tolerated, and then the loading will be gradually increased 2cm H2O per week or as symptom tolerated and according to the RPE scale. Throughout the first session training, the monitoring of oxygen saturation will be applied. And the load will be minimized if there is any decrease in oxygen saturation during loaded breathing Patients will take intermittent periods of rest if they feel uncomfortable; and if the patient cannot tolerate the increased resistance or the patients who are unable to finish full session training, and then those of last part of training will be continued. Patients will be warned to expect transient delayed-onset muscle soreness, a consequence of muscle adaptation to an unaccustomed activity. And training will be immediately stopped if they experience severe sharp pain on inspiration.
Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 4 weeks; then readmitted to hospital 2 weeks later . For checking the compliance of IMT at home, patients will be monitored by making a phone call to them twice a week. Or patient will receive an outpatient program about 10 weeks if they are not readmitted to our hospital, or patient will directly receive outpatient program if they cannot be admitted in the hospital..
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
inspiratory muscle training, stroke rehabilitation
Inspiratory muscle training with a pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) will be start at a resistance equal to 30% of their MIP or at a load which patient can tolerate, and then the loading will be gradually increased 2cm H2O per week or as symptom tolerated and according to the RPE scale. Each patient will receive regular post-stroke rehabilitation program.
Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA
Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 10 weeks
post-stroke rehabilitation program
control group
stroke rehabilitation.
post-stroke rehabilitation program
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA
Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 10 weeks
post-stroke rehabilitation program
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
20 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mei-Yun Liaw
Department of physical medicine and rehabilitation
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Liaw Mei-Yun, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
Kaohsiung, Taiwan, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
99-3663A3
Identifier Type: -
Identifier Source: org_study_id