The Hand-Held Fan and the Calming Hand for People With Chronic Breathlessness: A Feasibility Trial.

CONTEXT: The battery-operated hand-held fan ("fan") and the Calming Hand (CH), a cognitive strategy, are interventions used in clinical practice to relieve chronic breathlessness.

OBJECTIVE: To test the feasibility of a Phase III randomized controlled trial (RCT) evaluating the impact of the fan and/or CH compared with exercise advice alone for the relief of chronic breathlessness due to respiratory conditions.

METHODS: A single-site, feasibility "2 × 2" factorial, nonblinded, mixed-methods RCT was performed. Participants randomly allocated to four groups: fan + exercise advice, CH + exercise advice, fan + CH + exercise advice, and exercise advice alone. Measures included recruitment, acceptability, data quality and study outcomes (baseline and day 28), modified Incremental Shuttle Walk Test (mISWT), recovery time from exertion-induced breathlessness, life-space questionnaire, General Self-Efficacy Scale, and breathlessness numerical rating scales. Willing participants and carers were interviewed at study end.

RESULTS: Recruitment/acceptability/data completion: 53 people were screened, 40 randomized and completed (mean age 72 years (SD 9.8), 70% male). There were few missing data (mISWT, n = 2). Recovery time (seconds) from exertion-induced breathlessness showed most improvement for the fan; mean reduction from baseline -33.5 vs. CH mean increase from baseline 5.7. This represents a recovery speed at day 28 (-20.4%) faster for the fan vs. 4.1% slower for the CH. Qualitative data indicated participants valued the faster recovery and identified the fan as a useful "medical" device but found the CH unhelpful.

CONCLUSION: A Phase III RCT is feasible. Mixed-methods data synthesis supports recovery time as a novel, meaningful outcome measure.