Concurrent Training in Type 2 Diabetes (CONTRADIA)
|ClinicalTrials.gov Identifier: NCT03278704|
Recruitment Status : Terminated (Enrollment goal not met in allotted recruitment period)
First Posted : September 12, 2017
Last Update Posted : July 17, 2018
It is recommended that individuals perform a combination of resistance exercise (RE) and endurance exercise. Lack of time is often cited as a reason for being unable to meet current exercise guidelines. Therefore, combining both forms in one session may be beneficial. However, research continues to elucidate whether interference of adaptive outcomes occurs when RE and endurance exercise are performed concurrently. A proposed interference effect suggests that concurrent training may dampen RE-induced adaptations (e.g., muscle strength and growth) compared to RE only.
The propose of this investigation is to determine the effects of concurrent RE and high-intensity interval training (HIIT), compared to RE only, on muscle health and cardiovascular risk in sedentary, middle-aged (40-65 years) who are overweight/obese with type 2 diabetes mellitus (T2DM). The investigators will measure the effects on muscle strength, muscle growth, cardiovascular fitness, glycaemic control and markers of cardiovascular risk before and after an 8-week training program. Data will be obtained through the analysis of skeletal muscle samples, blood samples, magnetic resonance imaging, questionnaires and exercise performance tests.It is hypothesized that concurrent RE + HIIT will amplify the exercise-induced muscle growth response, which will result in greater satellite cell content, compared to RE alone. As a result, this will lead to greater skeletal muscle mass and strength after RE + HIIT compared to RE in isolation.
A finding that concurrent resistance training and HIIT does not impede muscle adaptations could offer future strategies to minimize exercise time commitment whilst still maximizing the physiological benefits of both resistance and endurance exercise through a single training session. This may therefore provide an effective exercise strategy in the prevention and/or treatment of T2DM.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Other: RE only Other: RE + HIIT||Not Applicable|
Data analysis will be performed using IBM SPSS statistical software (IBM Corp., Armonk, New York, USA). All data will be checked for normality and appropriate log transformations applied prior to analysis of variance (ANOVA) for primary and secondary outcomes. Satellite cell content will be compared using a two-way, mixed-model ANOVA with one within (2 levels; pre- and post-training) and one between factor (2 level; exercise group) with significance set at P < 0.05.
Based on a mixed ANOVA with between- and within-participant factors, and previously published data (Babcock et al. 2012), a sample size of 24 participants (12 per group) will provide a power of 84%. This sample size will allow detection of a mean change in satellite cell content of 2.35, assuming standard deviations of the change from pre- to post-training as 2.266 and 1.331 in the two exercise groups. Sample size calculation was performed with an alpha error of 0.05. SamplePower 2.0 (SPSS Inc., Chicago, Illinois, USA) software was used to determine sample size.
This study will combine data collected at the University of Birmingham with previously collected data from an identical study design performed by a co-investigator (Dr Pugh) in Rome, Italy. The previous study has collected data from 10 participants across both exercise groups (RE, N = 7; RE + HIIT, N = 3). Therefore, it is necessary for the present study to recruit a further 14 participants (RE, N = 5, RE + HIIT, N = 9) in order to achieve a sample size of 24 participants (12 per group). However, based on an assumption of a 25% drop-out rate, the total minimal sample necessary will be 19 participants (RE, N = 7; RE + HIIT, N = 12).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an exploratory randomized controlled trial. Participants will complete a parallel designed study, in which they will be randomly assigned to a resistance exercise (RE) only or concurrent RE and high-intensity interval training (RE + HIIT) group.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Concurrent Resistance Exercise and High-intensity Interval Exercise Training on Skeletal Muscle Adaptations in Individuals With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||December 6, 2017|
|Actual Primary Completion Date :||July 12, 2018|
|Actual Study Completion Date :||July 12, 2018|
RE training only
RE only - Progressive resistance exercise training only (leg extension, leg step up, chest press and pull down).
Other: RE only
8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise.
Experimental: Concurrent RE + HIIT
RE + HIIT - Progressive resistance exercise training (leg extension, leg step up, chest press and pull down) followed by HIIT (10 x 1 min at 90% heart rate maximum).
Other: RE + HIIT
8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise. Concurrent training: RE followed by HIIT within the same session.
- Change in fibre-type specific satellite cell content [ Time Frame: Prior to the 8-week training intervention and 72 hours after the last training session ]Assessed using immunofluorescence microscopy (Pax7-positive cells)
- Change in muscle-specific gene expression related to growth adaptations [ Time Frame: Prior to the 8-week training intervention and 72 hours after the last training session ]Assessed using reverse-transcription polymerase chain reactions
- Change in muscle fibre size [ Time Frame: Prior to the 8-week training intervention and 72 hours after the last training session ]Assessed using immunofluorescence microscopy techniques to determine muscle fibre type-specific cross-sectional area
- Change in muscle size [ Time Frame: Prior to the 8-week training intervention and 48 hours after the last training session ]Assessed using MRI to determine whole and individual muscle group cross-section area and total muscle volume
- Change in isometric muscle strength [ Time Frame: Prior to the 8-week training intervention and 6 days after the last training session ]Assessed using a dynamometer
- Change in isokinetic muscle strength [ Time Frame: Prior to the 8-week training intervention and 6 days after the last training session ]Assessed using a dynamometer
- Change in cardiorespiratory fitness [ Time Frame: Prior to the 8-week training intervention and 6 days after the last training session ]Assessed using a V̇O2 peak test on a cycle ergometer
- Change in habitual physical activity levels [ Time Frame: Prior to the 8-week training intervention and 1 week after the last training session ]Assessed using 7-day continuous accelerometry data
- Change in exercise enjoyment [ Time Frame: After the first and last training session ]Assessed using validated questionnaires (PACES)
- Change in glycaemic control [ Time Frame: Prior to the 8-week training intervention and 72 hours after the last training session ]Assessed using blood analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278704
|School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham|
|Birmingham, United Kingdom, B15 2TT|
|Principal Investigator:||Professor M Nimmo, PhD||University of Birmingham|