Coronary Heart DiseaseNCT05022498
Individual Variability of Coronary Heart Disease Risk Markers and Sleep Responses to Exercise
A study testing Exercise in people with Coronary Heart Disease and Cardiovascular Risk Factor, run by Loughborough University at 1 site in United Kingdom.
Trial summary
The aim of this study is to examine the reproducibility of postprandial coronary heart disease (CHD) risk marker and sleep responses to acute exercise bouts and to quantify the magnitude of individual variability in responses using a replicated crossover design. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Cardiovascular Risk Factor, Arterial Stiffness
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 13 Jul 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45-year-old men;
- Be able to run continuously for 1 hour;
- Body mass index between 18.5 and 29.9 kg/m2;
- No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
Who cannot join
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Uncontrolled exercise-induced asthma;
- Coagulation or bleeding disorders;
- Heart conditions;
- Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
- Taking any medication that might influence fat metabolism, blood glucose or appetite;
Show all 11Show fewer
- Smoking (including vaping);
- Dieting or restrained eating behaviours;
- Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
- Presence of any diagnosed sleeping disorder;
- A food allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Replicated Crossover Study Exploring Individual Variability of Postprandial Coronary Heart Disease Risk Markers and Sleep Quality in Response to Acute Exercise in Healthy Young Men
The aim of this study is to examine the reproducibility of postprandial coronary heart disease (CHD) risk marker and sleep responses to acute exercise bouts and to quantify the magnitude of individual variability in responses using a replicated crossover design. Healthy, recreationally active men will complete two identical rest control and two identical exercise (60 min at 60% maximum oxygen uptake) conditions in randomised sequences. Fasting and postprandial venous blood samples, arterial blood pressure and arterial stiffness measurements will be taken at pre-determined intervals, and sleep duration and quality will be assessed. Reproducibility and individual variability will be examined using bivariate correlations and linear mixed modelling.
Read the detailed description
Single bouts of exercise reduce circulating concentrations of postprandial triacylglycerol - an established independent risk marker for coronary heart disease (CHD). The exercise-induced reduction in postprandial triacylglycerol concentrations has been shown to coincide with transient changes in other CHD risk markers, including reductions in postprandial insulin, interleukin-6, arterial stiffness and resting arterial blood pressure, and exercise may also promote sleep duration and quality. Individual variability in these responses is suspected but has not been examined using robust designs and appropriate statistical models. A recent approach to quantify individual variability in the intervention response involves quantifying the participant-by-condition interaction from replicated intervention and comparator arms. Using this approach (the replicated crossover design), the present study will (i) examine whether the postprandial CHD risk marker and sleep responses to acute exercise are reproducible on repeated occasions; and (ii) determine whether there is true individual variability in postprandial CHD risk marker and sleep responses to acute exercise.
A total of 20 healthy, recreationally active men will be recruited. Participants will undertake a preliminary measures visit (visit 1) to confirm eligibility, to undergo anthropometric measurements and to determine maximum oxygen uptake. Participants will complete four, 2-day experimental conditions in randomised sequences separated by at least one week: two identical control and two identical exercise conditions. On day 1 (visits 2, 4, 6 and 8), participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and arterial stiffness measurement will be taken. Participants will consume a standardised high fat breakfast at 08:45 (0 h) and lunch at 12:45 (4 h). A second arterial stiffness measurement will be taken at 16:45 (8 h). The two control and two exercise conditions will be identical, except that participants will be asked to exercise on the treadmill for 60 minutes at 60% of their maximum oxygen uptake at 15:15 (6.5 h) in both exercise conditions. On day 2 (visits 3, 5, 7 and 9), participants will arrive fasted at 08:00 and will rest in the laboratory throughout the day in the two control and two exercise conditions. Participants will consume a standardised breakfast at 08:45 (0 h) and a standardised lunch at 12:45 (4 h). Venous blood samples will be collected at 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h. Resting arterial blood pressure will be measured at hourly intervals. Arterial stiffness will be measured at 0, 2.5 and 5 h. Sleep duration and quality will be assessed for three nights before and two nights after visits 3, 5, 7 and 9 using a triaxial actigraphy watch.
Reproducibility and individual variability will be explored by correlating the two sets of response differences between exercise and control conditions. Within-participant covariate-adjusted linear mixed models will be used to quantify participant-by-condition interactions. It is hypothesised that (i) control-adjusted postprandial CHD risk marker and sleep responses to acute exercise will be reproducible; and (ii) true interindividual variability will exist in postprandial CHD risk marker and sleep responses to acute exercise beyond any random within-subject variation.
- Conditions
- Coronary Heart Disease, Cardiovascular Risk Factor, Arterial Stiffness, Blood Pressure, Sleep
- Being tested
- Exercise
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
60 min treadmill exercise performed at 60% of maximum oxygen uptake.
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | No intervention | Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Control 2 | No intervention | Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Exercise 1 | Experimental | Participants will complete 60 min of treadmill exercise on day 1 (15:15-16:15). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. Receives: Behavioral: Exercise |
| Exercise 2 | Experimental | Participants will complete 60 min of treadmill exercise on day 1 (15:15-16:15). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma triacylglycerol concentration
Fasted plasma triacylglycerol concentration on day 1 and day 2. Time-averaged total area under the curve for triacylglycerol on day 2 in response to exercise and/or feeding.
Measured: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Secondary outcomes (16)
Plasma glucose concentration
Fasted plasma glucose concentration on day 1 and day 2. Time-averaged total area under the curve for glucose on day 2 in response to exercise and/or feeding.
Measured: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Plasma insulin concentration
Fasted plasma insulin concentration on day 1 and day 2. Time-averaged total area under the curve for insulin on day 2 in response to exercise and/or feeding.
Measured: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Plasma total cholesterol concentration
Fasted plasma total cholesterol concentration on day 1 and day 2.
Measured: Day 1: fasted; Day 2: fasted
Plasma high-density lipoprotein cholesterol concentration
Fasted plasma high-density lipoprotein cholesterol concentration on day 1 and day 2.
Measured: Day 1: fasted; Day 2: fasted
Plasma low-density lipoprotein cholesterol concentration
Fasted plasma low-density lipoprotein cholesterol concentration on day 1 and day 2.
Measured: Day 1: fasted; Day 2: fasted
Plasma C-reactive protein concentration
Fasted plasma C-reactive protein concentration on day 1 and day 2.
Measured: Day 1: fasted; Day 2: fasted
Apolipoprotein E
Apolipoprotein E genotype at baseline.
Measured: Day 1: fasted (baseline)
Resting arterial blood pressure
Fasted resting systolic and diastolic blood pressure on day 1 and day 2. Time-averaged total area under the curve for systolic and diastolic blood pressure on day 2 in response to exercise and/or feeding.
Measured: Day 1: fasted; Day 2: fasted (0 hours), 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours
Resting pulse wave analysis
Time-course of resting pulse wave analysis in response to exercise and/or feeding on day 1 and day 2.
Measured: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
Resting pulse wave velocity
Time-course of resting pulse wave velocity in response to exercise and/or feeding on day 1 and day 2.
Measured: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
Time in bed
Total time in bed between 'lights out' to 'lights on'.
Measured: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total sleep time
Total time asleep between 'lights out' to 'lights on'.
Measured: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Actual wake time
Total time awake after the first sleep period.
Measured: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Sleep onset latency
Total time from 'lights out' to the first sleep epoch.
Measured: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Sleep efficiency
Total sleep time expressed as a percentage of time in bed.
Measured: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Sleep fragmentation index
Number of times that sleep is terminated after one minute expressed as a percentage of the total sleep time.
Measured: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Oct 2019
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Teesside University
- Responsible party
- Principal investigator, Professor David Stensel, Loughborough University
- Investigators
- David Stensel, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022498
- Sponsor's protocol ID
- LU-R19-P103
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request.
Publications
Freese EC, Gist NH, Cureton KJ. Effect of prior exercise on postprandial lipemia: an updated quantitative review. J Appl Physiol (1985). 2014 Jan 1;116(1):67-75. doi: 10.1152/japplphysiol.00623.2013. Epub 2013 Nov 7.
PubMed 24201708Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
PubMed 25333969Kredlow MA, Capozzoli MC, Hearon BA, Calkins AW, Otto MW. The effects of physical activity on sleep: a meta-analytic review. J Behav Med. 2015 Jun;38(3):427-49. doi: 10.1007/s10865-015-9617-6. Epub 2015 Jan 18.
PubMed 25596964Goltz FR, Thackray AE, King JA, Dorling JL, Atkinson G, Stensel DJ. Interindividual Responses of Appetite to Acute Exercise: A Replicated Crossover Study. Med Sci Sports Exerc. 2018 Apr;50(4):758-768. doi: 10.1249/MSS.0000000000001504.
PubMed 29240652Goltz FR, Thackray AE, Atkinson G, Lolli L, King JA, Dorling JL, Dowejko M, Mastana S, Stensel DJ. True Interindividual Variability Exists in Postprandial Appetite Responses in Healthy Men But Is Not Moderated by the FTO Genotype. J Nutr. 2019 Jul 1;149(7):1159-1169. doi: 10.1093/jn/nxz062.
PubMed 31132105Atkinson G, Batterham AM. True and false interindividual differences in the physiological response to an intervention. Exp Physiol. 2015 Jun;100(6):577-88. doi: 10.1113/EP085070. Epub 2015 May 13.
PubMed 25823596Senn S, Rolfe K, Julious SA. Investigating variability in patient response to treatment--a case study from a replicate cross-over study. Stat Methods Med Res. 2011 Dec;20(6):657-66. doi: 10.1177/0962280210379174. Epub 2010 Aug 25.
PubMed 20739334Senn S. Mastering variation: variance components and personalised medicine. Stat Med. 2016 Mar 30;35(7):966-77. doi: 10.1002/sim.6739. Epub 2015 Sep 28.
PubMed 26415869Yang Y, Thackray AE, Shen T, Alotaibi TF, Alanazi TM, Clifford T, Hartescu I, King JA, Roberts MJ, Willis SA, Lolli L, Atkinson G, Stensel DJ. A replicate crossover trial on the interindividual variability of sleep indices in response to acute exercise undertaken by healthy men. Sleep. 2025 Mar 11;48(3):zsae250. doi: 10.1093/sleep/zsae250.
PubMed 39446630Shen T, Thackray AE, King JA, Alotaibi TF, Alanazi TM, Willis SA, Roberts MJ, Lolli L, Atkinson G, Stensel DJ. Are There Interindividual Responses of Cardiovascular Disease Risk Markers to Acute Exercise? A Replicate Crossover Trial. Med Sci Sports Exerc. 2024 Jan 1;56(1):63-72. doi: 10.1249/MSS.0000000000003283. Epub 2023 Aug 30.
PubMed 37703030
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Replicated Crossover Study Exploring Individual Variability of Postprandial Coronary Heart Disease Risk Markers and Sleep Quality in Response to Acute Exercise in Healthy Young Men
- ClinicalTrials.gov ID
- NCT05022498
- Acronym / sponsor ID
- LU-R19-P103
- Conditions
- Coronary Heart Disease, Cardiovascular Risk Factor, Arterial Stiffness, Blood Pressure, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Teesside University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 26 Aug 2021 (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 aim of this study is to examine the reproducibility of postprandial coronary heart disease (CHD) risk marker and sleep responses to acute exercise bouts and to quantify the magnitude of individual variability in responses using a replicated crossover design. Healthy, recreationally active men will complete two identical rest control and two identical exercise (60 min at 60% maximum oxygen uptake) conditions in randomised sequences. Fasting and postprandial venous blood samples, arterial blood pressure and arterial stiffness measurements will be taken at pre-determined intervals, and sleep duration and quality will be assessed. Reproducibility and individual variability will be examined using bivariate correlations and linear mixed modelling.
Detailed description
Single bouts of exercise reduce circulating concentrations of postprandial triacylglycerol - an established independent risk marker for coronary heart disease (CHD). The exercise-induced reduction in postprandial triacylglycerol concentrations has been shown to coincide with transient changes in other CHD risk markers, including reductions in postprandial insulin, interleukin-6, arterial stiffness and resting arterial blood pressure, and exercise may also promote sleep duration and quality. Individual variability in these responses is suspected but has not been examined using robust designs and appropriate statistical models. A recent approach to quantify individual variability in the intervention response involves quantifying the participant-by-condition interaction from replicated intervention and comparator arms. Using this approach (the replicated crossover design), the present study will (i) examine whether the postprandial CHD risk marker and sleep responses to acute exercise are reproducible on repeated occasions; and (ii) determine whether there is true individual variability in postprandial CHD risk marker and sleep responses to acute exercise.
A total of 20 healthy, recreationally active men will be recruited. Participants will undertake a preliminary measures visit (visit 1) to confirm eligibility, to undergo anthropometric measurements and to determine maximum oxygen uptake. Participants will complete four, 2-day experimental conditions in randomised sequences separated by at least one week: two identical control and two identical exercise conditions. On day 1 (visits 2, 4, 6 and 8), participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and arterial stiffness measurement will be taken. Participants will consume a standardised high fat breakfast at 08:45 (0 h) and lunch at 12:45 (4 h). A second arterial stiffness measurement will be taken at 16:45 (8 h). The two control and two exercise conditions will be identical, except that participants will be asked to exercise on the treadmill for 60 minutes at 60% of their maximum oxygen uptake at 15:15 (6.5 h) in both exercise conditions. On day 2 (visits 3, 5, 7 and 9), participants will arrive fasted at 08:00 and will rest in the laboratory throughout the day in the two control and two exercise conditions. Participants will consume a standardised breakfast at 08:45 (0 h) and a standardised lunch at 12:45 (4 h). Venous blood samples will be collected at 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h. Resting arterial blood pressure will be measured at hourly intervals. Arterial stiffness will be measured at 0, 2.5 and 5 h. Sleep duration and quality will be assessed for three nights before and two nights after visits 3, 5, 7 and 9 using a triaxial actigraphy watch.
Reproducibility and individual variability will be explored by correlating the two sets of response differences between exercise and control conditions. Within-participant covariate-adjusted linear mixed models will be used to quantify participant-by-condition interactions. It is hypothesised that (i) control-adjusted postprandial CHD risk marker and sleep responses to acute exercise will be reproducible; and (ii) true interindividual variability will exist in postprandial CHD risk marker and sleep responses to acute exercise beyond any random within-subject variation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control 1 | No intervention | –Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Control 2 | No intervention | –Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Exercise 1 | Experimental | Behavioral: ExerciseParticipants will complete 60 min of treadmill exercise on day 1 (15:15-16:15). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
| Exercise 2 | Experimental | Behavioral: ExerciseParticipants will complete 60 min of treadmill exercise on day 1 (15:15-16:15). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 45-year-old men;
- Be able to run continuously for 1 hour;
- Body mass index between 18.5 and 29.9 kg/m2;
- No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
Key exclusion criteria (11 listed)
- Musculoskeletal injury that has affected normal ambulation within the last month;
- Uncontrolled exercise-induced asthma;
- Coagulation or bleeding disorders;
- Heart conditions;
- Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
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 |
|---|---|---|
| Exercise60 min treadmill exercise performed at 60% of maximum oxygen uptake. | Behavioural | Exercise 1, Exercise 2 |
Primary outcome
Plasma triacylglycerol concentration
Time frame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Fasted plasma triacylglycerol concentration on day 1 and day 2. Time-averaged total area under the curve for triacylglycerol on day 2 in response to exercise and/or feeding.
16 secondary outcomes
Plasma glucose concentration
Time frame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Plasma insulin concentration
Time frame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Plasma total cholesterol concentration
Time frame: Day 1: fasted; Day 2: fasted
Plasma high-density lipoprotein cholesterol concentration
Time frame: Day 1: fasted; Day 2: fasted
Plasma low-density lipoprotein cholesterol concentration
Time frame: Day 1: fasted; Day 2: fasted
Plasma C-reactive protein concentration
Time frame: Day 1: fasted; Day 2: fasted
Apolipoprotein E
Time frame: Day 1: fasted (baseline)
Resting arterial blood pressure
Time frame: Day 1: fasted; Day 2: fasted (0 hours), 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours
Resting pulse wave analysis
Time frame: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
Resting pulse wave velocity
Time frame: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
Time in bed
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total sleep time
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Actual wake time
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Sleep onset latency
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Sleep efficiency
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Sleep fragmentation index
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 24201708Freese EC, Gist NH, Cureton KJ. Effect of prior exercise on postprandial lipemia: an updated quantitative review. J Appl Physiol (1985). 2014 Jan 1;116(1):67-75. doi: 10.1152/japplphysiol.00623.2013. Epub 2013 Nov 7.
- Background: PubMed 25333969Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.
- Background: PubMed 25596964Kredlow MA, Capozzoli MC, Hearon BA, Calkins AW, Otto MW. The effects of physical activity on sleep: a meta-analytic review. J Behav Med. 2015 Jun;38(3):427-49. doi: 10.1007/s10865-015-9617-6. Epub 2015 Jan 18.
- Background: PubMed 29240652Goltz FR, Thackray AE, King JA, Dorling JL, Atkinson G, Stensel DJ. Interindividual Responses of Appetite to Acute Exercise: A Replicated Crossover Study. Med Sci Sports Exerc. 2018 Apr;50(4):758-768. doi: 10.1249/MSS.0000000000001504.
- Background: PubMed 31132105Goltz FR, Thackray AE, Atkinson G, Lolli L, King JA, Dorling JL, Dowejko M, Mastana S, Stensel DJ. True Interindividual Variability Exists in Postprandial Appetite Responses in Healthy Men But Is Not Moderated by the FTO Genotype. J Nutr. 2019 Jul 1;149(7):1159-1169. doi: 10.1093/jn/nxz062.
- Background: PubMed 25823596Atkinson G, Batterham AM. True and false interindividual differences in the physiological response to an intervention. Exp Physiol. 2015 Jun;100(6):577-88. doi: 10.1113/EP085070. Epub 2015 May 13.
- Background: PubMed 20739334Senn S, Rolfe K, Julious SA. Investigating variability in patient response to treatment--a case study from a replicate cross-over study. Stat Methods Med Res. 2011 Dec;20(6):657-66. doi: 10.1177/0962280210379174. Epub 2010 Aug 25.
- Background: PubMed 26415869Senn S. Mastering variation: variance components and personalised medicine. Stat Med. 2016 Mar 30;35(7):966-77. doi: 10.1002/sim.6739. Epub 2015 Sep 28.
- Derived from this study: PubMed 39446630Yang Y, Thackray AE, Shen T, Alotaibi TF, Alanazi TM, Clifford T, Hartescu I, King JA, Roberts MJ, Willis SA, Lolli L, Atkinson G, Stensel DJ. A replicate crossover trial on the interindividual variability of sleep indices in response to acute exercise undertaken by healthy men. Sleep. 2025 Mar 11;48(3):zsae250. doi: 10.1093/sleep/zsae250.
- Derived from this study: PubMed 37703030Shen T, Thackray AE, King JA, Alotaibi TF, Alanazi TM, Willis SA, Roberts MJ, Lolli L, Atkinson G, Stensel DJ. Are There Interindividual Responses of Cardiovascular Disease Risk Markers to Acute Exercise? A Replicate Crossover Trial. Med Sci Sports Exerc. 2024 Jan 1;56(1):63-72. doi: 10.1249/MSS.0000000000003283. Epub 2023 Aug 30.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request.
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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.
David Stensel principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Coronary Heart Disease and Cardiovascular Risk Factor, run by Loughborough University at 1 site in United Kingdom.
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 4 inclusion and 11 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 17 Aug 2022. 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 United Kingdom. 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?
Plasma triacylglycerol concentration (time frame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours). 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 NCT05022498, which also lists 10 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 17 Aug 2022.