Weather Sensitivity and the Effects of Walking in Nature on Stress Response of Individuals With Coronary Artery Disease

NCT ID: NCT06139705

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Cardiac Rehabilitation Nature, Human Stress Reaction Cognitive Function 1, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Walking outdoors group (OUT group)

The OUT group will walk in natural environment.

Group Type EXPERIMENTAL

Walking outdoor

Intervention Type OTHER

The individuals will walk in park along a pre-designated route 20 min.

Walking indoors group (IN group)

The IN group will walk indoors.

Group Type EXPERIMENTAL

Walking indoor

Intervention Type OTHER

The individuals will walk in a gym on a treadmill 20 min.

Interventions

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Walking outdoor

The individuals will walk in park along a pre-designated route 20 min.

Intervention Type OTHER

Walking indoor

The individuals will walk in a gym on a treadmill 20 min.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dalia Martinaitiene

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nijole Kazukauskiene, Dr.

Role: PRINCIPAL_INVESTIGATOR

Lithuanians Uiversity of Health Sciences

Locations

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Laboratory of Behavioral Medicine, Neuroscience Institute, Lithuanian University of Health Sciences

Palanga, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Nijole Kazukauskiene, Dr.

Role: CONTACT

+370 698 35802

Dalia Martinaitiene, Dr.

Role: CONTACT

+37069873631

Facility Contacts

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Nijole Kazukauskiene, Dr

Role: primary

+37069835802

Dalia Martinaitiene

Role: backup

+37069873631

References

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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.

Reference Type BACKGROUND
PMID: 31688512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35432772 (View on PubMed)

Martinaitiene D, Sampaio F, Demetrovics Z, Gjoneska B, Portacenko J, Damuleviciute A, Garbenyte-Apolinskiene T, Burkauskas J, Kazukauskiene N. A randomised controlled trial assessing the effects of weather sensitivity profile and walking in nature on the psychophysiological response to stress in individuals with coronary artery disease. A study protocol. BMC Psychol. 2024 Feb 19;12(1):82. doi: 10.1186/s40359-024-01574-3.

Reference Type DERIVED
PMID: 38374158 (View on PubMed)

Other Identifiers

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S-MIP-23-114

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BE-2-9

Identifier Type: -

Identifier Source: org_study_id

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