Coronary Artery DiseaseSENSE_NATURENCT06139705
Weather Sensitivity and the Effects of Walking in Nature on Stress Response of Individuals With Coronary Artery Disease
A study testing Walking outdoor and Walking indoor in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Cardiac Rehabilitation, Nature, Human
- What is being tested?
- Walking outdoor and Walking indoor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jun 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Laboratory of Behavioral Medicine, Neuroscience Institute, Lithuanian University of Health Sciences
Palanga, 00135
Nijole Kazukauskiene, Dr, +37069835802, nijole.kazukauskiene@lsmu.lt
Dalia Martinaitiene, +37069873631, dalia.martinaitiene@lsmu.lt
About this study
Official title: 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.
Read the 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:
- To determine how walking in a natural environment affects the psychophysiological reactions to stress in individuals with CAD.
- To determine how walking in the gym affects the psychophysiological reactions to stress in individuals with CAD.
- To analyse the associations between the psychophysiological reactions to stress of individuals with CAD and the walking environment, considering the sensitivity to the weather.
- 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
- Coronary Artery Disease, Cardiac Rehabilitation, Nature, Human, Stress Reaction, Cognitive Function 1, Social
- Being tested
- Walking outdoor, Walking indoor
- Keywords
- coronary artery diseases, weather sensitivity, cardiac rehabilitation, nature, stress reaction, walking
- Medical subject headings
- Coronary Artery Disease, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking outdoorOther
The individuals will walk in park along a pre-designated route 20 min.
Walking indoorOther
The individuals will walk in a gym on a treadmill 20 min.
| Study group | Role | What they receive |
|---|---|---|
| Walking outdoors group (OUT group) | Experimental | The OUT group will walk in natural environment. Receives: Other: Walking outdoor |
| Walking indoors group (IN group) | Experimental | The IN group will walk indoors. Receives: Other: Walking indoor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two days
Secondary outcomes (2)
Weather sensitivity
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".
Measured: up to 5 minutes
Mental flexibility
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.
Measured: up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jun 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Martinaitiene, Lithuanian University of Health Sciences
- Investigators
- Nijole Kazukauskiene, Dr., Principal investigator, Lithuanians Uiversity of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139705
- Sponsor's protocol ID
- BE-2-9
- Other IDs
- S-MIP-23-114
- Acronym
- SENSE_NATURE
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31688512Abrignani 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.
PubMed 35432772Martinaitiene 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.
PubMed 38374158
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weather Sensitivity Profile and the Effects of Walking in Nature on Psychophysiological Stress Response in Individuals With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06139705
- Acronym / sponsor ID
- SENSE_NATURE / BE-2-9
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine how walking in a natural environment affects the psychophysiological reactions to stress in individuals with CAD.
- To determine how walking in the gym affects the psychophysiological reactions to stress in individuals with CAD.
- To analyse the associations between the psychophysiological reactions to stress of individuals with CAD and the walking environment, considering the sensitivity to the weather.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Walking outdoors group (OUT group) | Experimental | Other: Walking outdoorThe OUT group will walk in natural environment. |
| Walking indoors group (IN group) | Experimental | Other: Walking indoorThe IN group will walk indoors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking outdoorThe individuals will walk in park along a pre-designated route 20 min. | Other | Walking outdoors group (OUT group) |
| Walking indoorThe individuals will walk in a gym on a treadmill 20 min. | Other | Walking indoors group (IN group) |
Primary outcome
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.
2 secondary outcomes
Weather sensitivity
Time frame: up to 5 minutes
Mental flexibility
Time frame: up to 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 31688512Gecaite 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.
- Background: PubMed 35432772Abrignani 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.
- Derived from this study: PubMed 38374158Martinaitiene 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nijole Kazukauskiene, Dr. principal investigator
Lithuanians Uiversity of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking outdoor and Walking indoor in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nijole Kazukauskiene, Dr. (+370 698 35802, nijole.kazukauskiene@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychophysiological respond to stress (time frame: Two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06139705, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.