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Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective RCT.

NCT02614001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-11-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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

OTHER

post-stroke rehabilitation program

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Liaw Mei-Yun, MD · Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-05-31
Completion
2015-07-31

Countries

  • Taiwan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02614001 on ClinicalTrials.gov