Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients

Gazi University

Status: Completed

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Treatments: Device: Inspiratory muscle training; Device: Sham inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT02270346

GaziUniversity

Details and patient eligibility

About

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) causes various toxic effects in many body tissues, organs and systems such as immune, cardiovascular, pulmonary, gastrointestinal, neuroendocrine and musculoskeletal systems, liver, kidneys and skin.Available limited numbers of studies showed that inspiratory muscle weakness in allo-HSCT candidates and recipients. Although meta-analysis, systematic reviews and studies demonstrated beneficial effects of inspiratory muscle training on several outcomes in different disease groups; chronic obstructive pulmonary disease, bronchiectasis and heart failure, no published paper reported the effects of IMT in allo-HSC recipients.

Full description

Thirty-eight allo-HSCT recipients (˃100 days past post-transplant status) were included. Before and after 6-week IMT, maximal and submaximal exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, dyspnea and fatigue perception, depression and quality of life were evaluated. Primary outcome measurement was respiratory muscle strength, secondary outcomes were exercise capacity, dyspnea, peripheral muscle strength, quality of life, fatigue and depression.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allo-HSC recipients (˃100 days past post-transplant status),
• 18-65 years of age,
• Under standard medications

Exclusion criteria

• Having cognitive disorder, orthopedic problem or neurological disease that were affecting functional capacity,
• Additional heart and lung diseases such as asthma, chronic obstructive pulmonary disease, acute infections or pneumonia,
• Problems prevented performing assessment and training such as visual problems and mucositis

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device.

Treatment:

Device: Inspiratory muscle training

Control group

Sham Comparator group

Description:

Sham: Control group received sham inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .

Treatment:

Device: Sham inspiratory muscle training