The Effect of Green Walking on Myocardial Infarction Patients

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987462
• Other study ID #: KTU-ACIN-9286
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2023
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Quality of Life

Intervention

Other:
• Green walking
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.

Locations

Country	Name	City	State
Turkey	Gümüshane State Hospital and Gümüshane Kelkit State Hospital	Gümüshane

Sponsors (1)

Lead Sponsor	Collaborator
AYNUR CIN

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At the end of the 12-week period
Other	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.	At the end of the 12-week period
Other	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.	At the end of the 12-week period
Other	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.	At the end of the 12-week period
Other	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.	At the end of the 12-week period
Other	Body Mass Index	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.	At the end of the 12-week period
Primary	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.).	1 day before the study
Primary	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.	1 day before the study
Primary	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.	1 day before the study
Primary	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.	1 day before the study
Primary	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.	1 day before the study
Primary	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.	1 day before the study
Primary	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.	1 day before the study
Primary	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).	1 day before the study
Secondary	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.	in the middle of the study (6th week).
Secondary	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.	in the middle of the study (6th week).Then it was recorded The Blood Lipids and BMI Monitoring Form.
Secondary	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.	in the middle of the study (6th week).
Secondary	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.	in the middle of the study (6th week).