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The Influence of Walking at Different Times of Day on Blood Lipids and Inflammatory Markers

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
walking
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring coronary artery disease, walking, lipids, inflammatory markers, time of day

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patients were younger than 80 years;
  2. They had been diagnosed with coronary artery disease by coronary angiography (at least 1 main coronary artery having >50% luminal diameter stenosis);
  3. They were able to walk but had a sedentary lifestyle which was defined as no regular physical activity in excess of 30 min/day, for more than 3 days/week over the last 3 months.

Exclusion Criteria:

  1. valvular heart disease;
  2. atrial fibrillation;
  3. cardiomyopathy;
  4. myocarditis;
  5. uncontrolled chronic diseases;
  6. congestive heart failure or ejection fraction <50% by echocardiogram.

Sites / Locations

  • Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Morning walking

Evening walking

No walking

Arm Description

Participants were requested to walk in the morning at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded.

Participants were requested to walk in the evening at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded.

The control group was requested to maintain their usual level of physical activity.

Outcomes

Primary Outcome Measures

Blood lipids and inflammatory markers
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol,low-density lipoprotein cholesterol, lipoprotein a;inflammatory markers include white blood cell count, platelet count, fibrinogen

Secondary Outcome Measures

Blood lipids and inflammatory markers
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein, lipoprotein a; inflammatory markers include white blood cell count, platelet count, fibrinogen

Full Information

First Posted
June 22, 2013
Last Updated
June 26, 2013
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01887093
Brief Title
The Influence of Walking at Different Times of Day on Blood Lipids and Inflammatory Markers
Official Title
The Influence of Regular Walking at Different Times of Day on Blood Lipids and Inflammatory Markers in Sedentary Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It has been well known that moderate and regular levels of physical activity has a favorable effect on many of the established risk factors related to coronary artery disease (CAD). Given that exercise in the morning has a greater potential for inducing sudden cardiac death and myocardial ischemia, it may be sensible for patients with CAD not to take exercise at this time. Our previous study indicated that the protective effect of exercise in the evening was greater than morning. However, which times of day to exercise could achieve the greatest improvements in lipids and inflammatory markers remains unclear. The purpose of the present study was to investigate the responses of lipid profiles and inflammatory markers to walking at different times of day in sedentary patients with CAD.
Detailed Description
According to the inclusion and exclusion criteria, 330 patients with CAD between the ages of 40 and 80 years were recruited from the inpatient cardiology department of the First Affiliated Hospital of Nanjing Medical University. Informed consent was obtained from each participant after explaining the study protocols. Patients were randomly assigned to one of the three groups: control group (n=110), morning walking group (n=110) or evening walking group (n=110). The control group was requested to maintain their usual level of physical activity. Participants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. The protocol of exercise was identical, while the difference between the two groups was that one group was asked for walking in the morning and the other group walking in the evening. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to understand the information about walking and medication use. In the intervention groups, subjects whose compliance rate with their respectively walking program were less than 85% were excluded in the analysis. Additionally, all the participants were given an advice on quitting smoking and were provided with similar diets by a nutritionist, as to caloric intake and nutrients. Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, lipoprotein a, white blood cell count and platelet count, fibrinogen were measured before and after the intervention. The Kolmogorov-Smirnov test was used to check the normal distribution of all continuous variables. The values of normal distribution were expressed as mean±SD, and non-normal distribution data were presented as median (interquartile range). Baseline differences between groups were determined by one-way analysis of variance and chi-square analyses. Baseline and follow-up values within each group were compared using the paired t test. General linear models were used to adjust the differences in baseline values for dependent variables. And two-way ANOVA was used for determination of the improvements of lipids and inflammatory markers in three groups. The significance level was defined as P<0.05. All analyses were carried out using SPSS version 13.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, walking, lipids, inflammatory markers, time of day

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morning walking
Arm Type
Experimental
Arm Description
Participants were requested to walk in the morning at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded.
Arm Title
Evening walking
Arm Type
Experimental
Arm Description
Participants were requested to walk in the evening at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks. We demanded everyone to record the situation of walking including duration, distance and time daily in a log book. Each participant was telephoned at least once a week to ensure the adherence to the exercise program. Patients were called back every month to hand in the log book and to understand the information about medication use. Furthermore, at the beginning and end of the 12-week program, both the walking groups were supervised by researchers to walk for continuous three days and the duration and distance of walking were recorded.
Arm Title
No walking
Arm Type
No Intervention
Arm Description
The control group was requested to maintain their usual level of physical activity.
Intervention Type
Behavioral
Intervention Name(s)
walking
Intervention Description
Participants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks.One group was asked to walk in the morning and the other group was asked to walk in the evening.
Primary Outcome Measure Information:
Title
Blood lipids and inflammatory markers
Description
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol,low-density lipoprotein cholesterol, lipoprotein a;inflammatory markers include white blood cell count, platelet count, fibrinogen
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Blood lipids and inflammatory markers
Description
Blood lipids include total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein, lipoprotein a; inflammatory markers include white blood cell count, platelet count, fibrinogen
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients were younger than 80 years; They had been diagnosed with coronary artery disease by coronary angiography (at least 1 main coronary artery having >50% luminal diameter stenosis); They were able to walk but had a sedentary lifestyle which was defined as no regular physical activity in excess of 30 min/day, for more than 3 days/week over the last 3 months. Exclusion Criteria: valvular heart disease; atrial fibrillation; cardiomyopathy; myocarditis; uncontrolled chronic diseases; congestive heart failure or ejection fraction <50% by echocardiogram.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Qing Lian, Master
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

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The Influence of Walking at Different Times of Day on Blood Lipids and Inflammatory Markers

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