Molassiotis, A., Charalambous, A., Taylor, P., Stamataki, Z., & Summers, Y. (2015). The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: A feasibility randomised trial. Supportive Care in Cancer, 23, 1637–1645. 

DOI Link

Study Purpose

To assess the feasibility of inspiratory muscle training (IMT) in the lung cancer population and to explore changes in outcomes

Intervention Characteristics/Basic Study Process

Patients were randomized to either the standard care group or the intervention group, which received standard care and intervention of IMT, consisting of two supervised sessions, then home self-delivery of IMT with provided device (pressure threshold device) in five sessions weekly for 12 weeks of 30 minutes per day divided over two sessions. Assessments were completed at 4, 8, and 12 weeks.

Sample Characteristics

  • N = 46  
  • MEAN AGE = 69.5 years 
  • AGE RANGE = 51–85 years
  • MALES: 80.4%, FEMALES: 19.6%
  • KEY DISEASE CHARACTERISTICS: The study included patients with primary lung cancer or mesothelioma, refractory dyspnea, prognosis of less than three months as judged by a clinician, and an O2 saturation less than 85% at rest.
  • OTHER KEY SAMPLE CHARACTERISTICS: The study excluded patients who had received radiation to the chest within four weeks or chemotherapy within two weeks. It generally included patients with stable disease who were off treatment.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings—large cancer centers, but participants completed intervention in their homes
  • LOCATION: Two sites in the UK and one in Cyprus

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • Spirometry assessment (physiologic data)—forced vital capactiy (FVC), forced expiratory volume (FEV1), FEV1%, and peak expiratory flow (PEF)
  • Severity of breathlessness, distress caused by breathlessness, ability to cope with breathlessness, and satisfaction with management of breathlessness all assessed by patient self-report on a 0–10 numeric rating scale
  • Modified Borg Breathlessness Scale (MBBS) 
  • Short Form Chronic Respiratory Disease Questionnaire (SF-CRDQ)
  • Hospital Anxiety and Depression Scale (HADS)
  • Clinician assessement and patient self-report or hypercapnia (safety) 
  • Compliance measured with patient-maintained training diary
  • Chronic Respiratory Disease Questionnaire (CRDQ)

Results

This trial showed that IMT is feasible and acceptable for patients with lung cancer. In comparison of IMT group and control group, several outcomes, including worst breathlessness, average breathlessness, distress from breathlessness, ability to cope with breathlessness, satisfaction with management of breathlessness, fatigue, and depression and anxiety had improved for the IMT group over the control group. No differences were seen in spirometry and breathlessness between groups.

Conclusions

IMT is feasible and acceptable for patients with lung cancer and improved outcomes were seen for patients receiving IMT. However, this trial had a small sample size, so it cannot adequately draw solid conclusions regarding outcomes for patients with lung cancer undergoing IMT for breathlessness. Larger trials should be conducted to evaluate this.

Limitations

  • Small sample (< 100)
  • Findings not generalizable
  • This study included only patients with lung cancer.
  • Does not include those with breathlessness from metastasis
  • Does not quantify number of patients with other underlying lung disorders that may contribute to breathlessness
  • Excludes only those with unstable COPD

Nursing Implications

IMT may be of benefit for the treatment of breathlessness, but data are too weak due to the small sample size to strongly recommend IMT. In addition, the study included only patients with lung cancer. This study is inadequately powered to draw conclusions about outcomes and does not address any patients experiencing breathlessness from nonthoracic malignancies.