Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling

NCT ID: NCT05601713

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-28
• Study Completion Date: 2023-05-04

Brief Summary

The incidence and severity of hot weather and extreme heat events (heat waves) is increasing. As such, there is an urgent need to develop heat-alleviation strategies that can provide targeted protection for older adults who are at an elevated risk for heat-induced illnesses or death due to impaired body temperature and cardiovascular regulation. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals and cannot be used during power outages (e.g., heat-related rolling blackouts). Immersion of the lower limbs in cold water and/or the application of cold towels to the neck have been recommended as simple and sustainable alternatives to air-conditioning. However, empirical data to support the efficacy of these interventions for mitigating physiological strain and discomfort in older adults is lacking. To address this knowledge gap, this randomized crossover trial will evaluate the effect of lower limb immersion with and without application of cold towels to the neck on body core temperature, cardiovascular strain and autonomic function, dehydration, and thermal comfort in adults aged 65-85 years exposed to simulated heat wave conditions (38°C, 35% relative humidity) for 6 hours.

Conditions

Hyperthermia; Weather; Heat; Heat Stress; Heat Syncope; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

No cooling intervention (control)

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension.

Group Type: ACTIVE_COMPARATOR

No cooling (control)

Intervention Type: OTHER

Participants are exposed to 38°C, 35% relative humidity for 6 hours without cooling interventions (control condition). Drinking water is available ad libitum.

Lower limb immersion

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension.

Group Type: EXPERIMENTAL

Lower limb immersion

Intervention Type: OTHER

Participants are exposed to 38°C, 35% relative humidity for 6 hours. For the last 40 min of each hour, participants lower limbs are immersed in cool water (\~20°C) up to the level of mid calf. Drinking water is available ad libitum.

Lower limb immersion + neck cooling

Adults aged 65-85 years with or without type 2 diabetes and/or hypertension.

Group Type: EXPERIMENTAL

Lower limb immersion + neck cooling

Intervention Type: OTHER

Participants are exposed to 38°C, 35% relative humidity for 6 hours. For the last 40 min of each hour, participants lower limbs are immersed in cool water (\~20°C) up to the level of mid calf. During limb immersion, a towel soaked in cool water (\~20°C) is placed around the participants neck. The towel is re-wet half way through the 40-min limb immersion. Drinking water is available ad libitum.

Interventions

No cooling (control)

Participants are exposed to 38°C, 35% relative humidity for 6 hours without cooling interventions (control condition). Drinking water is available ad libitum.

Intervention Type: OTHER

Lower limb immersion

Participants are exposed to 38°C, 35% relative humidity for 6 hours. For the last 40 min of each hour, participants lower limbs are immersed in cool water (\~20°C) up to the level of mid calf. Drinking water is available ad libitum.

Intervention Type: OTHER

Lower limb immersion + neck cooling

Participants are exposed to 38°C, 35% relative humidity for 6 hours. For the last 40 min of each hour, participants lower limbs are immersed in cool water (\~20°C) up to the level of mid calf. During limb immersion, a towel soaked in cool water (\~20°C) is placed around the participants neck. The towel is re-wet half way through the 40-min limb immersion. Drinking water is available ad libitum.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female adults.
• Aged 65-85 years.
• Non-smoking.
• English or French speaking.
• Ability to provide informed consent.

Exclusion Criteria

• Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
• Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.)
• Cardiac abnormalities identified via 12-lead ECG during an incremental exercise test to volitional fatigue (performed for all participants).
• Peak aerobic capacity (VO2peak), as measured during an incremental exercise test to volitional fatigue, exceeding the 50th percentile of age- and sex-specific normative values published by the American College of Sports Medicine (ACSM).

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Glen P. Kenny

Full Professor, University Research Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glen P Kenny, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Robert D Meade, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Ronald J Sigal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Ottawa

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

H-11-20-6234

Identifier Type: -

Identifier Source: org_study_id