Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective RCT.
1 other identifier
interventional
48
1 country
1
Brief Summary
Objectives: Little has been known the effectiveness of respiratory muscle training in patients with both stroke and heart failure. To investigate the feasibility and effectiveness of the inspiratory muscle training (IMT) in the respiratory muscle strength, cardiopulmonary function, exercise capacity, fatigue and quality of life in stroke patients with congestive heart failure. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedNovember 25, 2015
November 1, 2015
1 year
November 23, 2015
November 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MIP, MEP
maximal inspiratory pressure, maximal expiratory pressure MIP was measured after maximal expiration with each subject seated and wearing a nose-clip, and MEP was measured after maximal inspiration. An experienced respiratory therapist who strongly urged the subjects to make maximum inspiratory and expiratory efforts at or near residual and total lung capacity, respectively, performed the measurements. Determinations were repeated until two technically satisfactory measurements were recorded, with the highest value used for calculations.
10 weeks
Secondary Outcomes (3)
The Stages of Heart Failure. NYHA (New York Heart Association) Classification
10 weeks
Pulmonary function tests
10 weeks
six-minute walk work (6MWORK)
10 weeks
Study Arms (2)
inspiratory muscle training, stroke rehabilitation
EXPERIMENTALInspiratory 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.
control group
OTHERstroke rehabilitation.
Interventions
Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 10 weeks
Eligibility Criteria
You may qualify if:
- stroke patients with stable CHF, NYHA(New York Heart Association) class I-III
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
Kaohsiung, Taiwan, 83305, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liaw Mei-Yun, MD
Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of physical medicine and rehabilitation
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 25, 2015
Study Start
May 1, 2011
Primary Completion
May 1, 2012
Study Completion
July 1, 2015
Last Updated
November 25, 2015
Record last verified: 2015-11