Clinical trial NCT06139705: Weather Sensitivity and the Effects of Walking in Nature on Stress Response of Individuals With Coronary Artery Disease
Official title: Weather Sensitivity Profile and the Effects of Walking in Nature on Psychophysiological Stress Response in Individuals With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Cardiac Rehabilitation
Nature, Human
Stress Reaction
Cognitive Function 1, Social
Keywords: coronary artery diseases
weather sensitivity
cardiac rehabilitation
nature
stress reaction
walking
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After baseline measurements, the patients will be randomly assigned to either walking outdoors (OUT) or walking indoors (IN) groups. OUT group will walk in the parke. IN group will walk in a gym on a treadmill. During both interventions, the patient will be supervised by researchers. The order and sequence of measurements within each trial will be the same.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to investigate how walking in different environments affects the psychophysiological responses to the stress of individuals with coronary artery disease (CAD) according to their weather sensitivity. Awareness about the potential influence of weather sensitivity on the psychophysiological reactions to stress in patients with CAD disease may contribute to the planning and implementation of actions leading to improved medical care services and preventative measures that help to avoid the worsening of health and well-being in the future.

Detailed description: The environment might influence one's course of a disease and health prospective through direct exposure to physical, chemical, social, and psychosocial risk factors, as well as indirectly, through behavior-related changes response to those factors. Classical risk factors only partially account for variations in the occurrence, incidence, and mortality of cardiovascular disease (CVD). Therefore, other, less-explored factors need to be taken in consideration when referring to CVD epidemiology.

The main goal of this clinical trial is to investigate how walking in different environments affects the psychophysiological responses to the stress of individuals with coronary artery disease (CAD) during rehabilitation. An experimental study will be carried out including individuals with CAD attending cardiac rehabilitation. The hypothesis is that psychophysiological reactions to stress in weather-sensitive (WS) individuals with CAD will differ from non-WS individuals when walking outdoors (in a natural environment).

To achieve the main goal, the following specific tasks will be implemented:

1. To determine how walking in a natural environment affects the psychophysiological reactions to stress in individuals with CAD.
2. To determine how walking in the gym affects the psychophysiological reactions to stress in individuals with CAD.
3. To analyse the associations between the psychophysiological reactions to stress of individuals with CAD and the walking environment, considering the sensitivity to the weather.
4. To determine the connections between mental flexibility and weather sensitivity.

The participants will be randomly assigned to either walking outdoors (OUT) or walking indoors (IN) groups. OUT group will walk in natural environment (in the park) along a pre-designated route. IN group will walk in a gym on a treadmill. The order and sequence of measurements within each trial will be the same. During both interventions, the participants will be supervised by investigators.

The idea is to increase knowledge about the impact of the natural environment on well-being and health and to provide more information to health professionals and the public. Awareness about the potential influence of weather sensitivity on the psychophysiological reactions to stress in patients with CAD disease may contribute to the planning and implementation of actions leading to improved medical care services and preventative measures that help to avoid the worsening of health and well-being in the future. Protective measures should be directed towards susceptible groups rather than the population. The outcomes of this experiment may have direct clinical applications for the use of different types of environments in cardiac rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. from 18 years and older,
2. diagnosis of CAD,
3. participation in the cardiac rehabilitation program,
4. able to hear, speak and read in Lithuanian, and
5. signed informed consent.

Exclusion Criteria:

1. coronary artery bypass graft surgery, other cardiac surgery graft,
2. cognitive or communicative disabilities or other severe comorbidities,
3. unstable cardiovascular status,
4. did not speak Lithuanian fluently,
5. did not consent in participating

Primary outcomes:
measure: Psychophysiological respond to stress
timeFrame: Two days
Secondary outcomes:
measure: Weather sensitivity
timeFrame: up to 5 minutes
measure: Mental flexibility
timeFrame: up to 60 minutes
Other outcomes:
Locations:
city: Palanga
country: Lithuania
facility: Laboratory of Behavioral Medicine, Neuroscience Institute, Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanians Uiversity of Health Sciences
name: Nijole Kazukauskiene, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gecaite J, Burkauskas J, Brozaitiene J, Mickuviene N. Cardiovascular Reactivity to Acute Mental Stress: THE IMPORTANCE OF TYPE D PERSONALITY, TRAIT ANXIETY, AND DEPRESSION SYMPTOMS IN PATIENTS AFTER ACUTE CORONARY SYNDROMES. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):E12-E18. doi: 10.1097/HCR.0000000000000457.
citation: Abrignani MG, Lombardo A, Braschi A, Renda N, Abrignani V. Climatic influences on cardiovascular diseases. World J Cardiol. 2022 Mar 26;14(3):152-169. doi: 10.4330/wjc.v14.i3.152.