Cambach 1997.
| Methods | RCT (cross‐over), patient recruitment: patients or clients of respiratory care clinic Setting: Local physiotherapy practices, Netherlands |
|
| Participants |
Control patients: n = 21, women: 66.7%, mean age: 53, mild‐moderate asthma (according to FEV1), FEV1: 84%, dyspnoea score (CRDQ): 18, ICS use: not reported Intervention patients: n = 22, women: 81.8%, mean age: 40, mild‐moderate asthma (according to FEV1), FEV1: 89%, dyspnoea score (CRDQ): 18, ICS use: not reported |
|
| Interventions |
Name and duration of programme: rehabilitation programme run in local physiotherapy practices during 3 mo before cross‐over Intervention group components Organisational ‐ patients: recreational activities Organisational ‐ healthcare professionals or system: course on pulmonary rehabilitation for physiotherapists Patient education: group sessions on normal or pathological respiration, medication treatment, inhalation technique and sanitation or resources; one on one education on techniques of breathing retraining and evacuation of mucus; exercise training; group sessions on relaxation techniques Frequency: 2 individual sessions of 45 min on breathing retraining and mucus evacuation; group sessions: 6 sessions of 45 min on education, exercise training 2 times/week for 90 min; recreational activities 1 time/week for 45 minutes; 6 relaxation sessions of 45 minutes Healthcare professionals involved: physiotherapists; nurses Control group components Usual care Number of components and dominant component: 6, organisational ‐ patients |
|
| Outcomes |
Patient level Quality of life: CRDQ score: fatigue, emotion, mastery, and dyspnoea scores Asthma symptoms and activity level: mean endurance time during cycling at 75% Wmax; mean cardiac frequency during cycling at 60% Wmax; mean walking distance Time of outcome measurement: at 3 months |
|
| Notes | First 3 months considered only (before cross‐over) CRDQ: Chronic Respiratory Disease Questionnaire |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomisation procedure with closed envelopes |
| Allocation concealment (selection bias) | Low risk | Block randomisation procedure with closed envelopes |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | No indication in text |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Total of 99 patients ‐ 10 dropouts = 89 randomised ‐ 23 loss to f/u (9 Iintervention and 14 control patients) = 66 patients included (74%) Baseline characteristics of 33 dropouts not significantly different from 66 completed. Similar rates of dropouts between groups. |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Other bias | Low risk | No other bias detected |
| Outcomes at baseline similar? | Unclear risk | No statistical test for asthma subgroup |
| Characteristics at baseline similar? | High risk | Significant difference between groups for age and FEV1 |
| Adequate protection against contamination? | Low risk | Unlikely that control group received intervention before cross‐over |