Figures
- FIGURE 1
Study design and flow of patient through the study protocol: a pilot single-centre randomised controlled crossover open (nonmasked) trial of hand-held fan therapy (HHFT) versus no HHFT during 6-min walk test (6MWT) in patients with COPD and modified Medical Research Council dyspnoea score ≥2.
Tables
- TABLE 1
Patient characteristics of the 14 patients who completed the randomised controlled crossover trial of fan therapy versus no fan therapy during 6-min walk test
Age (years) 66.50 (60.75–73.50) BMI (kg·m−2) 25.85 (20.60–30.25) Male/female 4/10 Smoking status Current smoker 6 Ex-smoker 8 Smoking (pack-years) 48.00 (25.75–82.60) mMRC dyspnoea score 3.00 (2.00–3.00) FEV1 (L) 1.30 (0.94–1.59) FEV1 (%) 63.00 (38.75–74.0) FVC (L) 2.30 (1.90–2.75) FVC (%) 82.00 (71.00–93.25) FEV1/FVC ratio 56.75 (47.43–63.50) CAT score 21.00 (12.25–29.75) Data are presented as median (interquartile range) or n. BMI: body mass index; mMRC: modified Medical Research Council; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; CAT: COPD Assessment Test.
- TABLE 2
Results observed in the primary randomised controlled crossover trial of fan therapy versus no fan therapy during 6-min walk test (6MWT) in patients with COPD
Allocation sequence AB (fan/no fan) Allocation sequence BA (no fan/fan) Overall treatment effect Group-level median (IQR) WIDiM (IQR) Group-level median (IQR) WIDiM (IQR) WIDiM (IQR) Period 1
fanPeriod 2
no fanWIDiM# Wilcoxon signed rank test¶ Period 1
no fanPeriod 2
fanWIDiM# Wilcoxon signed rank test¶ WIDiM# Wilcoxon signed rank test¶ Patients (n) 7 7 7 6 6 6 13 Subjective measures of breathlessness NRS+ 5.00 (3.75 to 6.25) 7.00 (6.25 to 8.25) −2.00 (−2.00 to −1.00) 0.02 4.00 (2.50 to 5.75) 3.00 (2.00 to 4.75) −0.50 (−1.25 to 0.00) 0.25 −1.00 (−2.00 to −0.50) <0.01 ΔNRS§ 3.00 (1.25 to 4.25) 5.00 (3.00 to 6.75) −1.50 (−2.00 to −1.00) 0.02 3.50 (2.25 to 4.75) 3.00 (1.75 to 3.25) −0.50 (−1.25 to 0.00) 0.25 −1.00 (−2.00 to −0.50) <0.01 NRS recovery time+ 110.00 (15.00 to 135.00) 210.00 (160.00 to 295.00) −90.00 (−205.00 to −32.50) 0.03 150.00 (75.00 to 195.00) 210.00 (165.00 to 227.50) 60.00 (10.00 to 65.00) 0.09 −10.00 (−78.75 to 50.00) <0.01 mBorg+ 3.00 (0.75 to 3.50) 4.00 (4.00 to 5.00) −1.00 (−2.50 to 0.25) 0.06 3.00 (2.00 to 4.50) 3.00 (1.00 to 3.50) 0.00 (−1.00 to 0.00) 0.50 −0.25 (−2.00 to 0.00) 0.02 ΔmBorg§ 2.00 (0.25 to 3.00) 3.50 (3.50 to 4.00) −1.00 (−2.50 to −0.25) 0.06 3.00 (1.75 to 3.50) 2.00 (0.75 to 3.00) 0.00 (−1.00 to 0.00) 0.50 −0.25 (−2.00. 0.00) 0.02 Objective measures of physiology HR+ 84.00 (74.00 to 89.50) 82.00 (79.00 to 96.00) −4.00 (−12.00 to 4.00) 0.38 96.00 (94.00 to 106.50) 92.00 (85.50 to 97.50) −3.00 (−5.50 to −2.00) 0.14 −3.50 (−7.50 to 1.00) 0.11 ΔHR§ 11.00 (5.50 to 14.00) 12.00 (8.50 to 19.00) −3.00 (−5.50 to −1.00) 0.20 15.00 (4.00 to 18.00) 2.00 (0.50 to 14.00) −3.00 (−5.50 to −1.00) 0.47 −3.00 (−5.75 to −0.25) 0.13 SpO2+ 96.00 (94.50 to 98.50) 97.00 (96.50 to 98.00) 0.00 (−1.00 to 1.00) 1.00 96.00 (95.00 to 96.50) 97.00 (95.00 to 97.00) 0.00 (−1.00 to 1.00) 0.94 0.00 (−1.00 to 1.00) 0.70 Δ SpO2§ 0.00 (−1.00 to 1.50) 0.00 (−1.00 to 1.00) 0.00 (−0.50 to 1.00) 1.00 0.00 (−1.50 to 0.50) 0.00 (−1.50 to 1.00) 0.00 (-1.00 to 1.00) 1.00 0.00 (−0.75 to 1.00) 1.00 Objective measures of functional response 6MWT distanceƒ (m) 404.00 (336.25 to 465.00) 400.00 (312.50 to 420.00) 25.00 (17.50 to 30.00) 0.02 330.00 (223.75 to 517.50) 383.00 (247.50 to 561.25) 15.00 (11.00 to 42.75) 0.02 21.25 (12.75 to 31.88) <0.01 6MWT stopsƒ (n) 0.00 (0.00 to 0.00) 0.00 (0.00 to 1.00) 0.00 (−0.50 to 0.00) 1.00 0.00 (0.00 to 2.00) 0.00 (0.00 to 1.50) 0.00 (0.00 to 0.00) 1.000 0.00 (0.00 to 0.00) 0.63 Only within-individual differences in the medians (WIDiMs) are used for estimating treatment effects; group-level medians are helpful in assessing carryover and order effects (see methods section). IQR: interquartile range; NRS: numerical rating scale; Δ: change; mBorg: modified Borg scale for breathlessness; HR: heart rate; SpO2: oxygen saturation measured by pulse oximetry. #: calculated so that positive values indicate higher scores for the fan condition and negative values indicate higher scores for the no-fan condition; ¶: exact significant, two-tailed; +: assessed post-exercise; §: change from pre- to post-exercise; ƒ: assessed during the exercise period.
- TABLE 3
Results observed in the repeated randomised controlled crossover trial of fan therapy versus no fan therapy during 6-min walk test (6MWT) in patients with COPD
Allocation sequence AB (fan/no fan) Allocation sequence BA (no fan/fan) Overall treatment effect Group-level median (IQR) WIDiM (IQR) Group-level median (IQR) WIDiM (IQR) WIDiM (IQR) Period 1
fanPeriod 2
no fanWIDiM# Wilcoxon signed rank test¶ Period 1
no fanPeriod 2
fanWIDiM# Wilcoxon signed rank test¶ WIDiM# Wilcoxon signed rank test¶ Patients (n) 7 7 7 7 7 7 13 Subjective measures of breathlessness NRS+ 5.00 (3.50 to 5.50) 5.50 (4.25 to 7.00) −1.00 (−1.00 to −0.75) 0.03 3.80 (0.75 to 6.00) 1.80 (0.38 to 5.00) −0.25 (−0.88 to 0.00) 0.25 −1.00 (−1.00 to 0.00) <0.01 ΔNRS§ 3.50 (2.25 to 3.75) 4.00 (2.75 to 4.75) −1.00 (−1.00 to −0.75) 0.03 1.80 (0.75 to 2.75) 1.80 (0.38 to 2.00) −0.25 (−0.88 to 0.00) 0.25 −1.00 (−1.00 to 0.00) <0.01 NRS recovery time+ 120.00 (75.00 to 180.00) 185.00 (152.50 to 277.50) −110.00 (−127.00 to −62.50) 0.02 175.00 (43.75 to 227.50) 105.00 (25.75 to 185.00) −17.00 (−102.50 to −11.00) 0.06 −65.00 (−130.00 to −20.00) <0.01 mBorg+ 3.00 (2.00 to 4.00) 4.00 (3.00 to 4.50) −1.00 (−2.00 to −0.50) 0.06 2.50 (0.88 to 5.25) 1.50 (0.25 to 5.00) −0.25 (−0.88 to 0.00) 0.250 −1.00 (−2.00 to 0.00) <0.01 ΔmBorg§ 3.00 (1.00 to 3.00) 3.00 (2.50 to 3.50) −1.00 (−2.00 to −0.50) 0.06 2.50 (0.88 to 3.00) 1.50 (0.25 to 2.00) −0.25 (−0.88 to 0.00) 0.25 −1.00 (−2.00 to 0.00) <0.08 Objective measures of physiology HR+ 89.00 (84.50 to 99.50) 87.00 (85.00 to 99.50) 0.00 (−4.50 to 1.50) 0.69 89.50 (86.75 to 91.50) 84.50 (81.75 to 90.25) −1.50 (−6.50 to 2.75) 0.69 0.00 (−6.00 to 2.00) 0.49 ΔHR§ 10.00 (5.00 to 15.00) 10.00 (10.00 to 12.00) 0.00 (−6.00 to 4.00) 0.88 6.00 (2.50 to 12.50) 5.50 (2.75 to 12.75) 1.00 (−2.00 to 2.50) 0.85 1.00 (−3.00 to 3.00) 0.96 SpO2+ 94.00 (92.50 to 95.50) 94.00 (93.00 to 97.00) 0.00 (−3.00 to 0.00) 0.25 98.0 (96.50 to 98.00) 96.50 (96.00 to 97.75) 0.00 (−0.75 to 0.00) 0.75 0.00 (−2.00 to 0.00) 0.16 Δ SpO2§ 0.00 (−3.50 to 1.00) −1.00 (−1.50–0.50) −1.00 (−2.50 to 1.50) 0.52 0.50 (−1.50 to 2.50) −0.50 (−1.00 to 0.00) −1.00 (−1.75 to 0.50) 0.53 −1.00 (−2.00 to 1.00) 0.29 Objective measures of functional response 6MWT distanceƒ (m) 282.50 (233.75 to 470.25) 265.00 (209.75 to 430.00) 28.00 (20.00 to 38.75) 0.06 432.50 (399.38 to 516.25) 531.30 (421.25 to 560.63) 22.50 (11.25 to 71.25) 0.06 28.00 (17.50 to 45.00) <0.01 6MWT stopsƒ (n) 0.00 (0.00 to 2.00) 1.00 (0.00 to 1.50) 0.00 (0.00 to 0.00) 1.00 0.00 (0.00 to 0.00) 0.00 (0.00 to 0.00) 0.00 (0.00 to 0.00) 1.00 0.00 (0.00 to 0.00) 0.75 Only within-individual differences in the medians (WIDiMs) are used for estimating treatment effects; group-level medians are helpful in assessing carryover and order effects (see methods section). IQR: interquartile range; NRS: numerical rating scale; Δ: change; mBorg: modified Borg scale for breathlessness; HR: heart rate; SpO2: oxygen saturation measured by pulse oximetry. #: calculated so that positive values indicate higher scores for the fan condition and negative values indicate higher scores for the no-fan condition; ¶: exact significant, two-tailed; +: assessed post-exercise; §: change from pre- to post-exercise; ƒ: assessed during the exercise period.
- TABLE 4
Patient-reported acceptability of hand-held fan (HHF) therapy during exercise
Question Median (IQR) Range (min–max) Overall acceptability How acceptable was it to use the HHF during the exercise test?
(1=completely unacceptable, 5=completely acceptable)4 (4–5) 3–5 Affective attitude How much did you like using the HHF during the walking test?
(1=strongly dislike, 5=strongly like)4 (3–5) 3–5 Burden How much additional effort was required to use the HHF during the walking test?
(1=no additional effort, 5=a huge additional effort)1 (1–3) 1–4 Self-efficacy How confident were you about using the HHF as instructed during the walking test?
(1=very unconfident, 5=very confident)5 (4–5) 1–5 Intervention coherence Do you understand how the HHF therapy was supposed to work?
(1=definitely do not understand, 5=completely understand)4 (3–5) 2–5 Perceived effectiveness How effective was the HHF in reducing breathlessness when walking?
(1=very ineffective, 5=very effective)4 (3–4) 3–5 How effective was the HHF therapy in helping you to recover your breathing after you finished walking?
(1=very ineffective, 5=very effective)4 (3–4) 3–5 Would you use a HHF to help with breathlessness in your everyday life?
(1=I definitely would not use it, 5=I definitely would use it)5 (4–5) 2–5 IQR: interquartile range.
