Inspiratory Muscle Training in Stroke Patients With Stable Congestive Heart Failure: a Prospective RCT.
Condition: Dyspnea
MeSH terms: Dyspnea; Heart Failure
Study type: Interventional

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.
    

Detailed description: 
      A total of forty stroke patients with stable CHF, NYHA (New York Heart Association) class
      I-III, aging between 20 to 85 year-old, will be eligible and randomly assigned into IMT and
      control group. The diagnosis of CHF is according to framingham Criteria. Consensus will be
      completed before our intervention. All technicians who performed the different measurements
      and assessed the outcomes were blinded to group assignments.

      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..
    

Intervention name(s): Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA; post-stroke rehabilitation program
Intervention type(s): Device; Other
Intervention description(s): Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: breathing training, congestive heart failure, stroke