search
Back to results

The Effect of Green Walking on Myocardial Infarction Patients

Primary Purpose

Myocardial Infarction, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Green walking
Sponsored by
AYNUR CİN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction focused on measuring Disease, Nature, Perception, Quality of Life, Green Walking, Myocardial Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inclusion criteria were being 18 years of age or older, being able to communicate verbally, being literate, having had MI at least three months ago, being followed up as an outpatient with the diagnosis of MI in the cardiology outpatient clinic of X state hospital and Y state hospital, achieving the six-minute walk test (6MWT), having no obstacle to walking (musculoskeletal problems, joint problems, fracture, neuropathy, chronic severe pain, limb loss) volunteering to participate in the study. Exclusion Criteria: having blood pressure above 140/90 mmHg or below 90/60 mmHg, having active chest pain, dyspnea, bradycardia, or tachycardia, a psychiatric diagnosis, visual, hearing, cognitive impairment, a balance problem, using a walker while walking, having Parkinson's disease, dementia, or cancer, having undergone any surgery that would prevent walking, refusing to participate in the study.

Sites / Locations

  • Gümüşhane State Hospital and Gümüşhane Kelkit State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Green Walk group

Control group

Arm Description

Patients who were admitted to the Cardiology Outpatient Clinic of Y State Hospital and passed the 6MWT conducted by the cardiology physician were eligible for participation in the green walk group. Following the physician's examination at the Cardiology Outpatient Clinic, the researcher conducted face-to-face interviews with the patients in a private room. During these interviews, the patients were administered the Structured Patient Information Form, Blood Lipids and BMI Monitoring Form, the Brief IPQ, and the MIDAS, and the collected data were recorded on the respective forms. Then, the researcher provided detailed information to the patients about green walking. For the randomized MI patients, two groups were formed, and they engaged in a 50-minute green walking three days a week for 12 weeks, under the guidance of the researcher. The green walk group's walks were scheduled differently for the two subgroups.

Patients who were admitted to the Cardiology Outpatient Clinic of X State Hospital and passed the 6MWT conducted by the cardiology physician were enrolled in the control group. Upon their visit to the outpatient clinic, the patients in this group underwent a face-to-face interview, during which they were administered the "Structured Patient Information Form," the "Blood Lipids and BMI Monitoring Form," the "Brief-IPQ," and the "MIDAS" as pretests. . The patients in the control group continued with their routine daily activities. No specific intervention or additional measures were implemented by the investigator in this group. Furthermore, a follow-up "Blood Lipids and BMI Monitoring Form" was administered to the patients during their visit to the Cardiology Outpatient Clinic in the middle of the study (6th week). At the end of the 12-week period, the patients in the control group underwent a posttest.

Outcomes

Primary Outcome Measures

The Structured Patient Information Form
Developed by the researcher after reviewing the literature, the form consisted of two parts. The first part included six questions to determine the sociodemographic characteristics of the patients (gender, age, education level, marital status, employment status, and occupation), and the second part included a total of 10 questions, including four questions to determine the characteristics related to the disease (when MI occurred, presence of MI risk factors, etc.).
The Blood Lipids and BMI Monitoring Form
This form was developed by the researcher in line with the literature. It included blood lipids (HDL, LDL, Triglyceride and Total cholesterol), height (cm), and weight (kg) measurements of the patients. BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). The blood lipid measurement results of the patients (1st-week measurement; 6th-week interim measurement; 12th-week measurement) were obtained from the patient file by the researcher during Cardiology Outpatient Clinic visits.
The Brief Illness Perception Questionnaire (Brief IPQ)
This scale was developed by Broadbent et al. in 2006. The nine-item section of the scale defines the emotional and cognitive aspects of illness perception. Each item in the scale consists of open-ended questions and is scored between 0 and 10. In the last item, the individual is asked to indicate three factors that he/she thinks are the cause of his/her illness. These items include consequences, timeline, personal control, treatment control, identity, illness concern, coherency, and emotional response, respectively. The highest and lowest scores are 80 and 0. On the scale, the positive reaction consists of the score given to three sub-dimensions (3rd, 4th, and 7th) with a score between 0-10, and the negative reaction consists of the score given to five sub-dimensions (1st, 2nd, 5th, 6th, and 8th). Sub-dimension (1st, 2nd, 5th, 6th, and 8th) items are reverse scored. High scores indicate a negative perception of illness.
The Myocardial Infarction Dimensional Assessment Scale (MIDAS)
The Turkish validity and reliability of the MIDAS, devised by David Thompson et al. in 2002, were examined by Uysal et al. (2008), and the Cronbach alpha value of the scale was calculated as 0.83. The scale includes 35 items and seven sub-dimensions, including physical activity, insecurity, emotional reaction, dependency, diet, concerns over medication, and side effects. The scoring of the scale is between 0 and 100. A high score on the scale indicates poor health status.
Weight
Weight was measured with a medical scale with a hospital-calibrated height scale while the patients were fasting, after removing their thick clothes and before the physician examination.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Height
Height measurements were performed with the patient standing barefoot with the head in the Frankfort plane and the feet side by side in a medical basin with a height meter calibrated by the hospital.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Body Mass Index
BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). Then it was recorded The Blood Lipids and BMI Monitoring Form.
Six-minute walk test
It is a widely used test to assess treatment response in moderately severe heart or lung disease or to assess functional capacity, which is a determinant of mortality and morbidity in a person with a one-time measurement (in diseases such as Alzheimer's, elderly patients, MS, Parkinson's, osteoarthritis, spinal cord injury, stroke).

Secondary Outcome Measures

The Blood Lipids and BMI Monitoring Form
This form was developed by the researcher in line with the literature. It included blood lipids (HDL, LDL, Triglyceride and Total cholesterol), height (cm), and weight (kg) measurements of the patients. BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). The blood lipid measurement results of the patients (1st-week measurement; 6th-week interim measurement; 12th-week measurement) were obtained from the patient file by the researcher during Cardiology Outpatient Clinic visits.
Weight
Weight was measured with a medical scale with a hospital-calibrated height scale while the patients were fasting, after removing their thick clothes and before the physician examination.
Height
Height measurements were performed with the patient standing barefoot with the head in the Frankfort plane and the feet side by side in a medical basin with a height meter calibrated by the hospital.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Body Mass Index
BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). Then it was recorded The Blood Lipids and BMI Monitoring Form.

Full Information

First Posted
July 2, 2023
Last Updated
August 3, 2023
Sponsor
AYNUR CİN
search

1. Study Identification

Unique Protocol Identification Number
NCT05987462
Brief Title
The Effect of Green Walking on Myocardial Infarction Patients
Official Title
Investigation of the Effect of Green Walking on Body Mass Index, Blood Lipids, Disease Perception, and Quality of Life in Patients With Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
AYNUR CİN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aimed to experimentally investigate the effect of green walking on body mass index, blood lipids, disease perception, and quality of life in patients with MI.The study aimed to experimentally investigate the effect of green walking on body mass index, blood lipids, disease perception, and quality of life in patients with MI. Research Question 1: What is the impact of green walking on the body mass index (BMI) of patients with MI? Research Question 2: How does green walking influence blood lipid levels (triglycerides, LDL, total cholesterol, and HDL) in patients with MI? Research Question 3: What is the effect of green walking on the perception of the disease in patients with MI? Research Question 4: How does green walking affect the quality of life of patients with MI? 2 Groups: Green walking group and control group
Detailed Description
Setting and Time of the Study The data were collected in the Cardiology Outpatient Clinic of X State Hospital and Y State Hospital between February and June 2022. Population and Sample of the Study The study population consisted of patients who were receiving outpatient care at the Cardiology Outpatient Clinic of X State Hospital and Y State Hospital and had experienced a myocardial infarction (MI) at least three months ago. To determine the appropriate sample size, a power analysis was conducted using the G*Power 3.1.9.6 program based on a previous study (23) involving MI patients. The power analysis resulted in a sample size of 34 patients in total, with 17 patients allocated to each group. This sample size was determined to achieve 80% power, an effect size of 0.87, and a margin of error of 5%. However, considering that increasing the sample size would decrease the standard error and increase the study power (24), each group was increased by 75%. As a result, a total of 60 patients, with 30 patients in each group, were included in the study. For practical reasons (geographical location, working conditions, and limited availability of myocardial infarction (MI) patients), a total of 30 MI patients who were being treated as outpatients at the Cardiology Outpatient Clinic of Y State Hospital and had experienced MI at least three months prior were assigned to the experimental group. Another 30 MI patients who were being followed up as outpatients at the Cardiology Outpatient Clinic of X State Hospital and had also experienced MI at least three months before were assigned to the control group using criterion sampling. Criterion sampling involves selecting individuals based on predetermined criteria or qualifications for the study's objectives. It is important to note that in this study, the assignment of patients into groups was not done through randomization or matching. However, statistical analyses of the descriptive and disease-related information of the patients indicated no significant differences between the groups. This outcome confirms that the descriptive and disease-related characteristics of the groups were similar, thereby achieving an equal and homogeneous distribution in the study. Green Walk Group Patients who were admitted to the Cardiology Outpatient Clinic of Y State Hospital and passed the six-minute walk test (6MWT) conducted by the cardiology physician were eligible for participation in the green walk group. Following the physician's examination at the Cardiology Outpatient Clinic, the researcher conducted face-to-face interviews with the patients in a private room. During these interviews, the patients were administered the Structured Patient Information Form, Blood Lipids and BMI Monitoring Form, the Brief IPQ, and the MIDAS, and the collected data were recorded on the respective forms. Then, the researcher provided detailed information to the patients about green walking. For the randomized MI patients, two groups were formed, and they engaged in a 50-minute green walking three days a week for 12 weeks, under the guidance of the researcher. The green walk group's walks were scheduled differently for the two subgroups. The first subgroup had their 50-minute walk on Monday, Wednesday, and Saturday, while the second subgroup had their walks on Tuesday, Thursday, and Sunday. This arrangement ensured a standardized time interval between green walks for both groups. Additionally, a follow-up Blood Lipids and BMI Monitoring Form was administered to the patients during their visit to the Cardiology Polyclinic in the middle of the study (6th week). At the end of the 12-week period, the patients in the green walk group underwent a posttest evaluation. Control Group: Patients who were admitted to the Cardiology Outpatient Clinic of X State Hospital and passed the 6MWT conducted by the cardiology physician were enrolled in the control group. Upon their visit to the outpatient clinic, the patients in this group underwent a face-to-face interview, during which they were administered the "Structured Patient Information Form," the "Blood Lipids and BMI Monitoring Form," the "Brief-IPQ," and the "MIDAS" as pretests. The information and data collected from these interviews were recorded on the respective forms. The patients in the control group continued with their routine daily activities. No specific intervention or additional measures were implemented by the investigator in this group. Furthermore, a follow-up "Blood Lipids and BMI Monitoring Form" was administered to the patients during their visit to the Cardiology Outpatient Clinic in the middle of the study (6th week). At the end of the 12-week period, the patients in the control group underwent a posttest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Quality of Life
Keywords
Disease, Nature, Perception, Quality of Life, Green Walking, Myocardial Infarction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green Walk group
Arm Type
Experimental
Arm Description
Patients who were admitted to the Cardiology Outpatient Clinic of Y State Hospital and passed the 6MWT conducted by the cardiology physician were eligible for participation in the green walk group. Following the physician's examination at the Cardiology Outpatient Clinic, the researcher conducted face-to-face interviews with the patients in a private room. During these interviews, the patients were administered the Structured Patient Information Form, Blood Lipids and BMI Monitoring Form, the Brief IPQ, and the MIDAS, and the collected data were recorded on the respective forms. Then, the researcher provided detailed information to the patients about green walking. For the randomized MI patients, two groups were formed, and they engaged in a 50-minute green walking three days a week for 12 weeks, under the guidance of the researcher. The green walk group's walks were scheduled differently for the two subgroups.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients who were admitted to the Cardiology Outpatient Clinic of X State Hospital and passed the 6MWT conducted by the cardiology physician were enrolled in the control group. Upon their visit to the outpatient clinic, the patients in this group underwent a face-to-face interview, during which they were administered the "Structured Patient Information Form," the "Blood Lipids and BMI Monitoring Form," the "Brief-IPQ," and the "MIDAS" as pretests. . The patients in the control group continued with their routine daily activities. No specific intervention or additional measures were implemented by the investigator in this group. Furthermore, a follow-up "Blood Lipids and BMI Monitoring Form" was administered to the patients during their visit to the Cardiology Outpatient Clinic in the middle of the study (6th week). At the end of the 12-week period, the patients in the control group underwent a posttest.
Intervention Type
Other
Intervention Name(s)
Green walking
Intervention Description
The researcher provided detailed information to the patients about green walking. For the randomized MI patients, two groups were formed, and they engaged in a 50-minute green walking three days a week for 12 weeks, under the guidance of the researcher. The green walk group's walks were scheduled differently for the two subgroups. The first subgroup had their 50-minute walk on Monday, Wednesday, and Saturday, while the second subgroup had their walks on Tuesday, Thursday, and Sunday. This arrangement ensured a standardized time interval between green walks for both groups.
Primary Outcome Measure Information:
Title
The Structured Patient Information Form
Description
Developed by the researcher after reviewing the literature, the form consisted of two parts. The first part included six questions to determine the sociodemographic characteristics of the patients (gender, age, education level, marital status, employment status, and occupation), and the second part included a total of 10 questions, including four questions to determine the characteristics related to the disease (when MI occurred, presence of MI risk factors, etc.).
Time Frame
1 day before the study
Title
The Blood Lipids and BMI Monitoring Form
Description
This form was developed by the researcher in line with the literature. It included blood lipids (HDL, LDL, Triglyceride and Total cholesterol), height (cm), and weight (kg) measurements of the patients. BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). The blood lipid measurement results of the patients (1st-week measurement; 6th-week interim measurement; 12th-week measurement) were obtained from the patient file by the researcher during Cardiology Outpatient Clinic visits.
Time Frame
1 day before the study
Title
The Brief Illness Perception Questionnaire (Brief IPQ)
Description
This scale was developed by Broadbent et al. in 2006. The nine-item section of the scale defines the emotional and cognitive aspects of illness perception. Each item in the scale consists of open-ended questions and is scored between 0 and 10. In the last item, the individual is asked to indicate three factors that he/she thinks are the cause of his/her illness. These items include consequences, timeline, personal control, treatment control, identity, illness concern, coherency, and emotional response, respectively. The highest and lowest scores are 80 and 0. On the scale, the positive reaction consists of the score given to three sub-dimensions (3rd, 4th, and 7th) with a score between 0-10, and the negative reaction consists of the score given to five sub-dimensions (1st, 2nd, 5th, 6th, and 8th). Sub-dimension (1st, 2nd, 5th, 6th, and 8th) items are reverse scored. High scores indicate a negative perception of illness.
Time Frame
1 day before the study
Title
The Myocardial Infarction Dimensional Assessment Scale (MIDAS)
Description
The Turkish validity and reliability of the MIDAS, devised by David Thompson et al. in 2002, were examined by Uysal et al. (2008), and the Cronbach alpha value of the scale was calculated as 0.83. The scale includes 35 items and seven sub-dimensions, including physical activity, insecurity, emotional reaction, dependency, diet, concerns over medication, and side effects. The scoring of the scale is between 0 and 100. A high score on the scale indicates poor health status.
Time Frame
1 day before the study
Title
Weight
Description
Weight was measured with a medical scale with a hospital-calibrated height scale while the patients were fasting, after removing their thick clothes and before the physician examination.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
1 day before the study
Title
Height
Description
Height measurements were performed with the patient standing barefoot with the head in the Frankfort plane and the feet side by side in a medical basin with a height meter calibrated by the hospital.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
1 day before the study
Title
Body Mass Index
Description
BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
1 day before the study
Title
Six-minute walk test
Description
It is a widely used test to assess treatment response in moderately severe heart or lung disease or to assess functional capacity, which is a determinant of mortality and morbidity in a person with a one-time measurement (in diseases such as Alzheimer's, elderly patients, MS, Parkinson's, osteoarthritis, spinal cord injury, stroke).
Time Frame
1 day before the study
Secondary Outcome Measure Information:
Title
The Blood Lipids and BMI Monitoring Form
Description
This form was developed by the researcher in line with the literature. It included blood lipids (HDL, LDL, Triglyceride and Total cholesterol), height (cm), and weight (kg) measurements of the patients. BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). The blood lipid measurement results of the patients (1st-week measurement; 6th-week interim measurement; 12th-week measurement) were obtained from the patient file by the researcher during Cardiology Outpatient Clinic visits.
Time Frame
in the middle of the study (6th week).
Title
Weight
Description
Weight was measured with a medical scale with a hospital-calibrated height scale while the patients were fasting, after removing their thick clothes and before the physician examination.
Time Frame
in the middle of the study (6th week).Then it was recorded The Blood Lipids and BMI Monitoring Form.
Title
Height
Description
Height measurements were performed with the patient standing barefoot with the head in the Frankfort plane and the feet side by side in a medical basin with a height meter calibrated by the hospital.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
in the middle of the study (6th week).
Title
Body Mass Index
Description
BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
in the middle of the study (6th week).
Other Pre-specified Outcome Measures:
Title
The Blood Lipids and BMI Monitoring Form
Description
This form was developed by the researcher in line with the literature. It included blood lipids (HDL, LDL, Triglyceride and Total cholesterol), height (cm), and weight (kg) measurements of the patients. BMI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). The blood lipid measurement results of the patients (1st-week measurement; 6th-week interim measurement; 12th-week measurement) were obtained from the patient file by the researcher during Cardiology Outpatient Clinic visits.
Time Frame
At the end of the 12-week period
Title
The Brief Illness Perception Questionnaire (Brief IPQ)
Description
This scale was developed by Broadbent et al. in 2006. The nine-item section of the scale defines the emotional and cognitive aspects of illness perception. Each item in the scale consists of open-ended questions and is scored between 0 and 10. In the last item, the individual is asked to indicate three factors that he/she thinks are the cause of his/her illness. These items include consequences, timeline, personal control, treatment control, identity, illness concern, coherency, and emotional response, respectively. The highest and lowest scores are 80 and 0. On the scale, the positive reaction consists of the score given to three sub-dimensions (3rd, 4th, and 7th) with a score between 0-10, and the negative reaction consists of the score given to five sub-dimensions (1st, 2nd, 5th, 6th, and 8th). Sub-dimension (1st, 2nd, 5th, 6th, and 8th) items are reverse scored. High scores indicate a negative perception of illness.
Time Frame
At the end of the 12-week period
Title
The Myocardial Infarction Dimensional Assessment Scale (MIDAS)
Description
The Turkish validity and reliability of the MIDAS, devised by David Thompson et al. in 2002, were examined by Uysal et al. (2008), and the Cronbach alpha value of the scale was calculated as 0.83. The scale includes 35 items and seven sub-dimensions, including physical activity, insecurity, emotional reaction, dependency, diet, concerns over medication, and side effects. The scoring of the scale is between 0 and 100. A high score on the scale indicates poor health status.
Time Frame
At the end of the 12-week period
Title
Weight
Description
Weight was measured with a medical scale with a hospital-calibrated height scale while the patients were fasting, after removing their thick clothes and before the physician examination.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
At the end of the 12-week period
Title
Height
Description
Height measurements were performed with the patient standing barefoot with the head in the Frankfort plane and the feet side by side in a medical basin with a height meter calibrated by the hospital.Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
At the end of the 12-week period
Title
Body Mass Index
Description
MI was calculated by dividing body weight by the square meter of height (BMI=kg/m2). Then it was recorded The Blood Lipids and BMI Monitoring Form.
Time Frame
At the end of the 12-week period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria were being 18 years of age or older, being able to communicate verbally, being literate, having had MI at least three months ago, being followed up as an outpatient with the diagnosis of MI in the cardiology outpatient clinic of X state hospital and Y state hospital, achieving the six-minute walk test (6MWT), having no obstacle to walking (musculoskeletal problems, joint problems, fracture, neuropathy, chronic severe pain, limb loss) volunteering to participate in the study. Exclusion Criteria: having blood pressure above 140/90 mmHg or below 90/60 mmHg, having active chest pain, dyspnea, bradycardia, or tachycardia, a psychiatric diagnosis, visual, hearing, cognitive impairment, a balance problem, using a walker while walking, having Parkinson's disease, dementia, or cancer, having undergone any surgery that would prevent walking, refusing to participate in the study.
Facility Information:
Facility Name
Gümüşhane State Hospital and Gümüşhane Kelkit State Hospital
City
Gümüşhane
ZIP/Postal Code
29000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effect of Green Walking on Myocardial Infarction Patients

We'll reach out to this number within 24 hrs