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

NCT06139705 | Unknown

• 2 other identifiers: BE-2-9S-MIP-23-114
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Psychophysiological respond to stress

  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 Outcomes (2)

• Weather sensitivity

  up to 5 minutes

• Mental flexibility

  up to 60 minutes

Study Arms (2)

Walking outdoors group (OUT group)

EXPERIMENTAL

The OUT group will walk in natural environment.

Other: Walking outdoor

Walking indoors group (IN group)

EXPERIMENTAL

The IN group will walk indoors.

Other: Walking indoor

Interventions

Walking outdoor OTHER

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

Walking outdoors group (OUT group)

Walking indoor OTHER

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

Walking indoors group (IN group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• coronary artery bypass graft surgery, other cardiac surgery graft,
• cognitive or communicative disabilities or other severe comorbidities,
• unstable cardiovascular status,
• did not speak Lithuanian fluently,
• did not consent in participating

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

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

Palanga, 00135, Lithuania

RECRUITING

Related Publications (3)

• 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.

  PMID: 31688512 BACKGROUND

• 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.

  PMID: 35432772 BACKGROUND

• 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.

  PMID: 38374158 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Fractures, Stress

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Fractures, Bone; Wounds and Injuries

Study Officials

• Nijole Kazukauskiene, Dr.

  Lithuanians Uiversity of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nijole Kazukauskiene, Dr.

CONTACT

+370 698 35802; nijole.kazukauskiene@lsmu.lt

Dalia Martinaitiene, Dr.

CONTACT

+37069873631; dalia.martinaitiene@lsmu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: June 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)