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Using thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial

Efficacy of thermal clothing in reducing hospitalisations during winter for heart failure patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001023549
Enrollment
91
Registered
2015-10-01
Start date
2016-04-05
Completion date
2016-06-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Winter is a surprisingly dangerous time in Australia with greatly increased rates of death and hospitalisation. Winter death rates are 47% higher for heart failure and 32% higher for hypertensive disease compared with summer. Warm countries like Australia have a far greater winter increase in morbidity and mortality than cold countries like Sweden. This is because many Australian homes are inadequately insulated or heated, with indoor temperatures in winter often below 18 degrees C. This cold exposure increases blood pressure and inflammatory factors, which increases the risk of an acute cardiovascular event. Home insulation and heating have both been proven to improve cardiovascular health and wellbeing during winter. This study will test if personal insulation also improves cardiovascular health. Heart failure patients will be randomised to receive no intervention or a pack containing thermal tops, hats and socks, indoor temperature monitors, and advice on when to wear the thermals. Our primary hypothesis is that winter hospital admissions will be reduced, and we will also examine improvements in blood pressure, inflammatory factors, quality of life, sleep and personal insulation. This will be the world’s largest study of the health benefits of personal insulation, and will build on our work with heart failure patients at The Prince Charles Hospital. Thermal clothes are a cheap and simple intervention that could greatly reduce winter morbidity and mortality across Australia.

Interventions

Thermal clothing: two thermal tops, two pairs of thermal socks, one thermal hat. A large display indoor temperature monitor to be placed inside the home. A single A4 advisory sheet on when to wear the thermals, with the recommendation to wear the thermals in the following circumstances: 1. If the indoor temperature is below 18.0 degrees C when you wake up, then wear the thermals under your normal clothes during the day. 2. If the indoor temperature is below 18.0 degrees C degrees just before y

Thermal clothing: two thermal tops, two pairs of thermal socks, one thermal hat. A large display indoor temperature monitor to be placed inside the home. A single A4 advisory sheet on when to wear the thermals, with the recommendation to wear the thermals in the following circumstances: 1. If the indoor temperature is below 18.0 degrees C when you wake up, then wear the thermals under your normal clothes during the day. 2. If the indoor temperature is below 18.0 degrees C degrees just before you go to bed, then wear the thermals in bed. 3. If you are going outside for 10 minutes or more and the outdoor temperature is below 18.0 degrees C, then wear the thermals under your normal clothes. The intervention period is from 1 May 2016 to 30 September 2016 (5 months). Adherence to the thermals will be monitored using a self-completed clothing diary for one week during July 2016.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Have a diagnosis of either systolic or diastolic heart failure

Exclusion criteria

1. Are pregnant (highly unlikely). 2. A serious co-morbidity (e.g., cancer) or a serious physical impairment that prevents the participant from dressing themselves. 3. Live in a residential care facility. 4. Are unable to give informed consent. 5. Were involved in our previous pilot.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026