SPIRIT trial registration dataset80
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | ClinicalTrials.gov Identifier: NCT00953342 |
| Date of registration in primary registry | 4 August 2009 |
| Secondary identifying numbers | MOP93807 |
| Source(s) of monetary or material support | Canadian Institutes of Health Research |
| Primary sponsor | Canadian Institutes of Health Research |
| Secondary sponsor(s) | Concordia University, Hôpital du Sacré-Cœur de Montréal |
| Contact for public queries | SLB |
| Contact for scientific queries | SLB |
| Public title | Impact of Aerobic Exercise on Asthma Morbidity (Ex-asthma study) |
| Scientific title | Impact of Aerobic Exercise on Asthma Morbidity (Ex-asthma study) |
| Countries of recruitment | Canada |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention(s) | Active comparator: 12 weeks of supervised aerobic exercise and standard carePlacebo comparator: 12 weeks of standard care |
| Key inclusion and exclusion criteria | Inclusion criteria: ▸ Physician-diagnosed asthma (confirmed by medical record evidence of bronchodilator reversibility of 12% or a minimum of 180 cc or PC20 methacholine ≤16 mg/mL) ▸ Sedentary (currently do less than 60 min of structured/planned physical activity per week) ▸ Taking at least 250 mg fluticasone equivalent per day ▸ On stable dose and regimen of asthma medications ▸ Mild-to-moderate symptomatic asthma as defined by an Asthma Control Questionnaire score of 1.25 or greater Exclusion criteria: ▸ Diagnosed comorbid disease for which there are already established exercise guidelines, that is, cardiac disease or COPD ▸ Any other medical condition that confers greater illness morbidity than asthma (eg, active cancer) which will be confirmed by physician review ▸ FEV1 lower than 60% of predicted ▸ Incapable of exercising ▸ A BMI>30 kg/m2 ▸ Unable to speak or understand either French or English ▸ <18 years of age ▸ Patients who are currently pregnant or intend to become pregnant over the course of the study |
| Study type | Interventional Allocation: randomised Endpoint classification: efficacy study Intervention model: parallel assignment Masking: single blind (outcomes assessor) Primary purpose: treatment Phase III |
| Date of first enrolment | January 2010 |
| Target sample size | 104 |
| Recruitment status | Recruiting |
| Primary outcome(s) | Asthma control Questionnaire (Juniper) ( time frame: within 1 week of completion of the intervention (ie, after 12 weeks) |
| Key secondary outcomes | ▸ Asthma quality of life questionnaire (Juniper) ( time frame: within 1 week of completion of the intervention (ie, after 12 weeks)) ▸ Asthma control test (time frame: within 1 week of completion of the intervention (ie, after 12 weeks)) ▸ Inflammatory markers (time frame: within 1 week of completion of the intervention (ie, after 12 weeks)) |
Of note, a full SPIRIT checklist is provided as a supplementary file.
BMI, body mass index; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s.