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

November 15, 2023 updated by: Dalia Martinaitiene, Lithuanian University of Health Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Lithuania
      • Palanga, Lithuania, 00135
        • Recruiting
        • Laboratory of Behavioral Medicine, Neuroscience Institute, Lithuanian University of Health Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Walking outdoors group (OUT group)
The OUT group will walk in natural environment.
Other: Walking outdoor
The individuals will walk in park along a pre-designated route 20 min.
Experimental: Walking indoors group (IN group)
The IN group will walk indoors.
Other: Walking indoor
The individuals will walk in a gym on a treadmill 20 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychophysiological respond to stress
Time Frame: Two days
The primary outcome is psychophysiological reaction to stress. Psychophysiological stress responses will be assessed by hemodynamic parameters and cortisol level. concentration in saliva. Hemodynamic parameters will be measured using a long-term blood pressure device, which simultaneously, continuously, and non-reactively records blood pressure, ECG, and oxygen saturation, allowing comparative analysis of several vital parameters. A long-term BP monitor will be placed on the participant in the morning, duration of measurement up to 24 hours. Cortisol levels will be measured from saliva. Saliva samples will be obtained from participants using saliva sampling tubes. Samples will then be stored at -70 zero of Celsius and cortisol levels will be determined in a licensed laboratory using commercial reagent kits. Saliva samples will be taken five times: two times a day before experiment, three times - during experiment. One sampling procedure duration up to 2 min.
Two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weather sensitivity
Time Frame: up to 5 minutes
To assess weather sensitivity, individuals will be filled in Palanga self-assessment diary for weather sensitivity (PSAD-WS). PSAD-WS is an 11-item (general) three-factor tool for collecting information regarding weather sensitivity in patients with CAD. The three subscales reflected 1) psychological symptoms, 2) cardiac symptoms and 3) physical. Also, individuals will be asked a single question: "Do you feel the weather changes?" with possible answers of "NO" or "YES".
up to 5 minutes
Mental flexibility
Time Frame: up to 60 minutes
Mental flexibility will be evaluated using Cambridge Neuropsychological Test Automated Battery (CANTAB). CANTAB evaluate alterations in executive function. Specifically, the following tests is used: Motor screening Task - sensorimotor function; Cambridge Gambling Test - decision making (impulsivity, risk taking); Delayed Matching to Sample - short-term visual recognition memory; Intra-Extra Dimensional Set Shift - set-shifting, mental flexibility; Match to Sample Visual Search - attention and visual searching; One Touch Stockings - spatial planning and the working memory; Rapid Visual Information Processing - sustained attention; Spatial Working Memory - working memory.
up to 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Investigators

  • Principal Investigator: Nijole Kazukauskiene, Dr., Lithuanians Uiversity of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-2-9
  • S-MIP-23-114 (Other Grant/Funding Number: Research Council of Lithuania)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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