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Coronary Artery DiseaseNCT01887093

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

A study testing walking in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteChina
Study dates
Sep 2011to Mar 2013
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • valvular heart disease;
  • atrial fibrillation;
  • cardiomyopathy;
  • myocarditis;
  • uncontrolled chronic diseases;
  • congestive heart failure or ejection fraction <50% by echocardiogram.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

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

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.

Read the 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.

Being tested
walking
Keywords
coronary artery disease, walking, lipids, inflammatory markers, time of day
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • walkingBehavioural

    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.

Study groups in NCT01887093
Study groupRoleWhat they receive
Morning walkingExperimentalParticipants 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.
Receives: Behavioral: walking
Evening walkingExperimentalParticipants 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.
Receives: Behavioral: walking
No walkingNo interventionThe control group was requested to maintain their usual level of physical activity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

Secondary outcomes (1)
  1. 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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2013 (estimated)
  2. Study startSep 2011
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
Masking
None (open label)
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887093
Sponsor's protocol ID
NSFC(No. 81270255)
Other IDs
81270255
Status last verified
Jun 2013
First submitted
22 Jun 2013
Last updated
27 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.

    PubMed 17671237
  • Boardley D, Fahlman M, Topp R, Morgan AL, McNevin N. The impact of exercise training on blood lipids in older adults. Am J Geriatr Cardiol. 2007 Jan-Feb;16(1):30-5. doi: 10.1111/j.1076-7460.2007.05353.x.

    PubMed 17215640
  • Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000 Sep;32(9 Suppl):S498-504. doi: 10.1097/00005768-200009001-00009.

    PubMed 10993420
  • Andreotti F, Davies GJ, Hackett DR, Khan MI, De Bart AC, Aber VR, Maseri A, Kluft C. Major circadian fluctuations in fibrinolytic factors and possible relevance to time of onset of myocardial infarction, sudden cardiac death and stroke. Am J Cardiol. 1988 Sep 15;62(9):635-7. doi: 10.1016/0002-9149(88)90669-8. No abstract available.

    PubMed 3137799
  • Elherik K, Khan F, McLaren M, Kennedy G, Belch JJ. Circadian variation in vascular tone and endothelial cell function in normal males. Clin Sci (Lond). 2002 May;102(5):547-52.

    PubMed 11980574
  • Fahlman MM, Boardley D, Lambert CP, Flynn MG. Effects of endurance training and resistance training on plasma lipoprotein profiles in elderly women. J Gerontol A Biol Sci Med Sci. 2002 Feb;57(2):B54-60. doi: 10.1093/gerona/57.2.b54.

    PubMed 11818424
  • Geffken DF, Cushman M, Burke GL, Polak JF, Sakkinen PA, Tracy RP. Association between physical activity and markers of inflammation in a healthy elderly population. Am J Epidemiol. 2001 Feb 1;153(3):242-50. doi: 10.1093/aje/153.3.242.

    PubMed 11157411
  • Jahangard T, Torkaman G, Ghoosheh B, Hedayati M, Dibaj A. The effect of short-term aerobic training on coagulation and fibrinolytic factors in sedentary healthy postmenopausal women. Maturitas. 2009 Dec 20;64(4):223-7. doi: 10.1016/j.maturitas.2009.09.003. Epub 2009 Oct 24.

    PubMed 19854593
  • Jones H, Pritchard C, George K, Edwards B, Atkinson G. The acute post-exercise response of blood pressure varies with time of day. Eur J Appl Physiol. 2008 Oct;104(3):481-9. doi: 10.1007/s00421-008-0797-4. Epub 2008 Jun 20.

    PubMed 18566827
  • Kanaley JA, Weltman JY, Pieper KS, Weltman A, Hartman ML. Cortisol and growth hormone responses to exercise at different times of day. J Clin Endocrinol Metab. 2001 Jun;86(6):2881-9. doi: 10.1210/jcem.86.6.7566.

    PubMed 11397904
  • Kelley GA, Kelley KS, Tran ZV. Walking, lipids, and lipoproteins: a meta-analysis of randomized controlled trials. Prev Med. 2004 May;38(5):651-61. doi: 10.1016/j.ypmed.2003.12.012.

    PubMed 15066369
  • Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.

    PubMed 12421890
  • Lee CD, Folsom AR, Nieto FJ, Chambless LE, Shahar E, Wolfe DA. White blood cell count and incidence of coronary heart disease and ischemic stroke and mortality from cardiovascular disease in African-American and White men and women: atherosclerosis risk in communities study. Am J Epidemiol. 2001 Oct 15;154(8):758-64. doi: 10.1093/aje/154.8.758.

    PubMed 11590089
  • Lippi G, Franchini M, Salvagno GL, Montagnana M, Guidi GC. Higher morning serum cortisol level predicts increased fibrinogen but not shortened APTT. J Thromb Thrombolysis. 2008 Oct;26(2):103-5. doi: 10.1007/s11239-007-0074-0. Epub 2007 Jul 13.

    PubMed 17629773
  • Maresca G, Di Blasio A, Marchioli R, Di Minno G. Measuring plasma fibrinogen to predict stroke and myocardial infarction: an update. Arterioscler Thromb Vasc Biol. 1999 Jun;19(6):1368-77. doi: 10.1161/01.atv.19.6.1368.

    PubMed 10364066

Questions about this trial

What is this clinical trial studying?

A study testing walking in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jun 2013. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood lipids and inflammatory markers (time frame: 12 weeks). 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 NCT01887093, which also lists 16 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 27 Jun 2013.

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