Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT03530202
Status:
UNKNOWN
Last Update Posted:
2018-05-21
First Post:
2018-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of High-velocity Resistance Training and Creatine Supplementation in Healthy Aging Males
Sponsor:
University of Regina
Organization:
Study Overview
Official Title:
The Effect of High-velocity Resistance Training (HVRT) and Creatine Supplementation in Healthy Aging Males
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The age-related loss of skeletal muscle mass (i.e. sarcopenia)and muscle performance (i.e. strength and power), decreases functionality and the ability to perform activities of daily living. Therefore, lifestyle interventions which may improve aging muscle health are important (i.e. resistance training and creatine supplementation). High-velocity resistance training (HVRT) has been shown to increase muscle mass and muscle performance in aging adults. Creatine (CR), a compound naturally found in red meat and seafood, has also been shown to increase muscle mass and muscle performance in aging adults. No study has examined the combined effects of HVRT and CR supplementation in aging adults. This study may determine whether this lifestyle intervention is effective to combat sarcopenia.
Detailed Description:
Purpose and hypothesis: The purpose of this thesis is to compare the effects of HVRT and CR supplementation to HVRT and placebo in healthy aging males. It is hypothesized that HVRT and CR supplementation will increase muscle mass, strength, power and tasks of functionality compared to HVRT and placebo.
Participants: An a priori power analysis (G\*Power v. 3.1.5.1) indicated that 34 participants are required. This is based on a moderate effect size (Cohen's d = 0.25), an alpha level of .05, a ß-value of 0.8 for a repeated measures, within-between analysis of variance (ANOVA) design. Males (≥ 50 years) who are not engaged in resistance training for ≥ 6 weeks prior to the start of the study will be recruited. Participants will be informed of the risks and purposes of the study before written consent is obtained. The study will be approved by the Research Ethics Board at the University of Regina.
Methods and Research Design: The study will be a double-blind, repeated measures design. Participants will be randomized on a 1:1 basis to one of two groups: HVRT and CR or HVRT and placebo. The CR dosage will be 0.1g/kg/day as this dosage is effective for increasing muscle mass in aging males without resulting in adverse effects. On training days, participants will consume their supplement immediately after each training session mixed in water, juice or milk as post-exercise CR ingestion enhances its uptake into muscle and promotes increased muscle mass.
High-velocity Resistance Training Program: Participants will perform 3 sets of repetitions at 80% baseline 1-repetition maximum (1-RM) for the leg press, leg extension, leg curl, chest press, biceps curl, and triceps extension 2 times per week, for 8 weeks. Participants will perform the concentric phase of each muscle contraction as quickly as possible and will take 2 seconds to perform the eccentric phase.
Primary Dependent Variables
1. Muscle thickness: Muscle thickness will be assessed by B-mode ultrasound (LOGIQ e, GE Medical Systems) on knee flexors, knee extensors, elbow flexors, and elbow extensors in the Aging Muscle and Bone Health Laboratory, University of Regina.
2. Muscle strength: Leg press and chest press strength will be assessed using a 1-RM testing procedure in the Aging Muscle and Bone Health Laboratory, University of Regina.
3. Muscle power: Torque (Nm) and power (watts) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
4. Functionality tests: Dynamic balance will be measured as the time taken to perform backwards tandem walking over a distance of 6m on a 10cm-wide board that is raised about 4cm off the ground. Walking speed will be assessed by the time needed to walk an 80 m course.
Statistical Analyses: A 2 (group: CR vs. placebo) x 2 (time: pre- vs. post-training) repeated measures ANOVA will be used to determine differences between groups over time for the dependent variables. A one-factor ANOVA will be used to assess baseline characteristics and total training volume between groups. Significance will be set at an alpha level of 0.05 and all results will be expressed as means ± standard deviation. The magnitude of the difference between significant means will be determined by eta squared (η2). Statistical analyses will be performed using IBM SPSS Statistics, v. 24.
Participants: An a priori power analysis (G\*Power v. 3.1.5.1) indicated that 34 participants are required. This is based on a moderate effect size (Cohen's d = 0.25), an alpha level of .05, a ß-value of 0.8 for a repeated measures, within-between analysis of variance (ANOVA) design. Males (≥ 50 years) who are not engaged in resistance training for ≥ 6 weeks prior to the start of the study will be recruited. Participants will be informed of the risks and purposes of the study before written consent is obtained. The study will be approved by the Research Ethics Board at the University of Regina.
Methods and Research Design: The study will be a double-blind, repeated measures design. Participants will be randomized on a 1:1 basis to one of two groups: HVRT and CR or HVRT and placebo. The CR dosage will be 0.1g/kg/day as this dosage is effective for increasing muscle mass in aging males without resulting in adverse effects. On training days, participants will consume their supplement immediately after each training session mixed in water, juice or milk as post-exercise CR ingestion enhances its uptake into muscle and promotes increased muscle mass.
High-velocity Resistance Training Program: Participants will perform 3 sets of repetitions at 80% baseline 1-repetition maximum (1-RM) for the leg press, leg extension, leg curl, chest press, biceps curl, and triceps extension 2 times per week, for 8 weeks. Participants will perform the concentric phase of each muscle contraction as quickly as possible and will take 2 seconds to perform the eccentric phase.
Primary Dependent Variables
1. Muscle thickness: Muscle thickness will be assessed by B-mode ultrasound (LOGIQ e, GE Medical Systems) on knee flexors, knee extensors, elbow flexors, and elbow extensors in the Aging Muscle and Bone Health Laboratory, University of Regina.
2. Muscle strength: Leg press and chest press strength will be assessed using a 1-RM testing procedure in the Aging Muscle and Bone Health Laboratory, University of Regina.
3. Muscle power: Torque (Nm) and power (watts) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
4. Functionality tests: Dynamic balance will be measured as the time taken to perform backwards tandem walking over a distance of 6m on a 10cm-wide board that is raised about 4cm off the ground. Walking speed will be assessed by the time needed to walk an 80 m course.
Statistical Analyses: A 2 (group: CR vs. placebo) x 2 (time: pre- vs. post-training) repeated measures ANOVA will be used to determine differences between groups over time for the dependent variables. A one-factor ANOVA will be used to assess baseline characteristics and total training volume between groups. Significance will be set at an alpha level of 0.05 and all results will be expressed as means ± standard deviation. The magnitude of the difference between significant means will be determined by eta squared (η2). Statistical analyses will be performed using IBM SPSS Statistics, v. 24.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: