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The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02528305
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Abertay University
Information provided by (Responsible Party):
Niels Vollaard, University of Bath

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-alcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Intervention Other: High-intensity Interval Training
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High-intensity Interval Training (HIT)
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6 week control period with no intervention then 6 weeks of twice weekly HIT

High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12.

Period Title: Overall Study
Started 12
End of Control Period Assessment 11
End of Intervention Period Assessment 9
Completed 9
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Adverse Event             1
Physician Decision             1
Arm/Group Title High-intensity Interval Training (HIT)
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6 week control period with no intervention then 6 weeks of twice weekly HIT

High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
45  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
height  
Mean (Standard Deviation)
Unit of measure:  Metres
Number Analyzed 12 participants
1.71  (0.09)
body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants
29.6  (3.8)
diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants
Non-alcoholic Fatty Liver Disease (NAFLD) 7
Non-alcoholic Steatohepatitis (NASH) 5
1.Primary Outcome
Title Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Hide Description calculation of insulin resistance via formula: fasting insulin (mIU/L) x fasting glucose (mg/dL)/405 normal insulin resistance -HOMA score <3 moderate insulin resistance -HOMA score 3-5 severe insulin resistance -HOMA score >5 Assessed at baseline, after 6 week control period and within 1 week of completing 6 weeks HIT
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
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on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.9  (4.7) 9.6  (10.5) 7.0  (4.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.474
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Oral Glucose Tolerance Test
Hide Description measurement of capillary samples for glucose at time 0, followed by every 20 minutes for 2 hours following ingestion of 75g glucose. Results graphed against time, then area under the curve calculated for each of the 3 assessments.
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
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on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/L*min
981  (136) 1030  (182) 1010  (247)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title AST: ALT Ratio
Hide Description

ratio of liver enzymes aspartate aminotransferase (AST) to alanine aminotransferase (ALT).

used as a diagnostic aid e.g. AST:ALT of more than 2:1 is characteristic of alcoholic liver disease whereas fatty steatosis and many other causes of liver disease, ratio is less than or equal to 1.

Ratio may rise as fibrosis and cirrhosis develop in viral hepatitis.

Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
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on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: ratio
0.5  (0.2) 0.5  (0.2) 0.5  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title FIB-4
Hide Description

calculated from AST, ALT, platelets and participant's age and used to estimate amount of fibrosis in liver.

Fib-4 score of <1.45 has negative predictive value of 90% for advanced fibrosis.

Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
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on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: Fibrosis Score
0.68  (0.18) 0.60  (0.19) 0.60  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Body Fat Mass Estimated Via Bioimpedance
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
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on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: percentage body fat
total fat 29.7  (8.2) 29.5  (8.3) 28.3  (7.1)
trunk fat 26.6  (6.0) 29.1  (5.4) 28.6  (5.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Total body fat
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Trunk fat
6.Primary Outcome
Title Blood Pressure
Hide Description taken with participant supine, measured on left arm
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: mmHg
systolic blood pressure 139  (18) 142  (13) 136  (19)
diastolic blood pressure 85  (13) 87  (10) 78  (8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.771
Comments [Not Specified]
Method ANOVA
Comments For the analysis of systolic blood pressure
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANOVA
Comments For the analysis of diastolic blood pressure
7.Primary Outcome
Title General Well-being as Assessed by SF-36 Questionnaire
Hide Description Assessment of: physical functioning, social functioning, mental health, pain, change in health, physical role limitation, mental role limitation, energy and vitality, health perception over preceding 4 weeks (other than change in health, which is a comparison to health the preceding year), expressed as a transformed score range 0-100, with a higher score indicating better function/freedom from pain etc
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
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on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Function 79  (25) 85  (22) 92  (16)
Social Function 78  (31) 82  (27) 83  (27)
Mental Health 71  (17) 69  (20) 77  (20)
Pain 78  (13) 72  (28) 88  (16)
Change in Health 50  (18) 53  (15) 67  (18)
Physical Role Limitation 79  (27) 79  (31) 90  (22)
Mental Role Limitation 76  (24) 76  (34) 81  (30)
Energy/Vitality 58  (18) 56  (20) 64  (21)
Health Perception 58  (19) 60  (17) 61  (17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Physical Function
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.566
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Social Function
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Mental Health
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.145
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Pain
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Change in Health
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Physical Role Limitation
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Mental Role Limitation
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.366
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Energy/Vitality
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method ANOVA
Comments For the analysis of Health Perception
8.Primary Outcome
Title Short-term Memory Recall
Hide Description testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: words
6  (2) 7  (1) 6  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Primary Outcome
Title Estimated VO2 Max
Hide Description VO2 max estimated via submaximal exercise test-submaximal treadmill walking test Calculated via formula: VO2max= 15.1+21.8 x speed (miles per hour) - 0.327 x heart rate (beats per minute) - 0.263 x speed x age (years) + 0.00504 x heart rate x age + 5.98 x gender (0=female, 1=male)
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: millilitres/kilogram/minute
34.9  (6.5) 37.6  (7.2) 38.5  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Primary Outcome
Title Physical Function-"Get up and go" Test
Hide Description participant will be timed standing up from chair unaided,walking 30m, turning round and returning to a seated position on the chair, the average time of 3 attempts will be recorded.
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: seconds
6.61  (0.77) 6.23  (0.59) 5.87  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Primary Outcome
Title Ankle Brachial Pressure Index (ABPI)
Hide Description ratio of blood pressure in left arm and right ankle
Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: ABPI
1.15  (0.16) 1.08  (0.18) 1.13  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.793
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Primary Outcome
Title Long-term Memory Recall
Hide Description

testing of verbal word presentation-delayed recall of 10 words 10 minutes after words initially presented (within 60 seconds).

Maximum= 10 words, minimum = no words

Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: words
4  (1) 5  (2) 5  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.513
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
13.Primary Outcome
Title Executive Function (Verbal Fluency Test)
Hide Description

written verbal fluency test: participant asked to write down as many English words as possible within 60 seconds, starting with a particular letter of the alphabet, excluding proper nouns or plurals.

Baseline assessment-letter A Post Control assessment -letter S After HIT assessment -letter F

Time Frame Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Assessment After 6 Week Control Period After HIT Assessment
Hide Arm/Group Description:
on entry to trial
repeat assessment after 6 weeks of no intervention
final assessment within 1 week of completing 6 weeks of HIT
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: words
8  (4) 12  (4) 11  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline Assessment, After 6 Week Control Period, After HIT Assessment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High-intensity Interval Training (HIT)
Hide Arm/Group Description

6 week control period with no intervention then 6 weeks of twice weekly HIT

High-intensity Interval Training: 2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12.

All-Cause Mortality
High-intensity Interval Training (HIT)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High-intensity Interval Training (HIT)
Affected / at Risk (%) # Events
Total   1/12 (8.33%)    
Cardiac disorders   
Myocardial Infarction * [1]  1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
[1]
occurred at home during 6 week period of HIT intervention. Cardiologist concluded HIT had not contributed to his infarction
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High-intensity Interval Training (HIT)
Affected / at Risk (%) # Events
Total   0/12 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Niels Vollaard
Organization: University of Striling
Phone: +441786466488
Responsible Party: Niels Vollaard, University of Bath
ClinicalTrials.gov Identifier: NCT02528305     History of Changes
Other Study ID Numbers: 2015CM
First Submitted: August 10, 2015
First Posted: August 19, 2015
Results First Submitted: December 5, 2016
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018