- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03530202
Effects of High-velocity Resistance Training and Creatine Supplementation in Healthy Aging Males
The Effect of High-velocity Resistance Training (HVRT) and Creatine Supplementation in Healthy Aging Males
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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.
- 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.
- 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.).
- 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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Darren G Candow, PhD
- Phone Number: (306) 585-4906
- Email: Darren.Candow@uregina.ca
Study Contact Backup
- Name: John P Neary, PhD
- Phone Number: (306) 585-4844
- Email: Patrick.Neary@uregina.ca
Study Locations
-
-
Saskatchewan
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Regina, Saskatchewan, Canada, S4S4J5
- Recruiting
- University of Regina
-
Principal Investigator:
- Darren G Candow, PhD
-
Contact:
- Darren G Candow, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males (≥ 50 years) who are not engaged in supervised resistance training for ≥ 6 weeks prior to the start of the study will be recruited to participate.
Exclusion Criteria:
- Participants will be excluded if they have taken medications that affect muscle biology or creatine monohydrate ≤ 12 weeks prior to the start of the study
- If they have a history of fragility fractures; diseases that are known to affect muscle biology (i.e. corticoids)
- If they suffer from severe osteoarthritis
- If they are currently participating in moderate-vigorous resistance training (≥ 3 times per week)
- If they are vegetarian
- If they are planning to travel during the study period for greater than 2 weeks duration at a time.
- Participants with kidney or liver abnormalities will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HVRT + Creatine Monohydrate
Participants will perform 8-weeks of high-velocity resistance training, defined as performing the concentric phase of a lift as fast as possible and taking two seconds to perform the eccentric phase of the lift, on six exercises (bilateral legpress, leg extension, leg curl, chest press, triceps extension, and biceps curl) and consume creatine monohydrate powder.
The load will be 80% of the participants one-repetition max (1RM; the maximum weight that can be successfully lifted one time with proper form).
|
Participants will consume creatine monohydrate powder (Creapure, AlzChem AG, Trostberg, Germany) every day for 8 weeks.
On training days participants will consume supplement immediately after each training session (~ 5 minutes) mixed in water as post-exercise creatine ingestion enhances its uptake into muscle and promotes increased muscle mass.
On non-training days, supplements will be consumed at the participant's leisure.
Other Names:
|
Placebo Comparator: HVRT + Maltodextrin Powder
Participants will perform 8-weeks of high-velocity resistance training, defined as performing the concentric phase of a lift as fast as possible and taking two seconds to perform the eccentric phase of the lift, on six exercises (bilateral legpress, leg extension, leg curl, chest press, triceps extension, and biceps curl) and consume maltodexterin powder.
The load will be 80% of the participants one-repetition max (1RM; the maximum weight that can be successfully lifted one time with proper form).
|
Participants will consume Maltodextrin Powder (Globe Plus 10 DE Maltodextrin Powder, Univar Canada) every day for 8 weeks.
On training days participants will consume supplement immediately after each training session (~ 5 minutes) mixed in water.
On non-training days, supplements will be consumed at the participant's leisure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle thickness
Time Frame: Baseline and again once intervention is completed (8 weeks)
|
Muscle thickness (right side) of the elbow flexors, elbow extensors, knee flexors, and knee extensors will be measured using B-Mode ultrasound (LOGIQ e, GE Medical Systems).
|
Baseline and again once intervention is completed (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle strength
Time Frame: Baseline and again once intervention is completed (8 weeks)
|
Leg press and chest press strength will be assessed using a 1-repetition maximum (1-RM) standard testing procedure in the Aging Muscle and Bone Health Laboratory, University of Regina.
|
Baseline and again once intervention is completed (8 weeks)
|
Change in peak torque (Nm)
Time Frame: Baseline and again once intervention is completed (8 weeks)
|
Peak torque (Nm) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
|
Baseline and again once intervention is completed (8 weeks)
|
Change peak muscle power (watts)
Time Frame: Baseline and again once intervention is completed (8 weeks)
|
Peak muscle power (watts) will be measured for the knee flexors and extensors using an isokinetic dynamometer (Biodex System 3, Biodex Medical Systems Inc.).
|
Baseline and again once intervention is completed (8 weeks)
|
Change in dynamic balance
Time Frame: Baseline and again once intervention is completed (8 weeks)
|
Dynamic balance will be measured as the time taken to perform backwards tandem walking (i.e.
toe to heel) over a distance of 6m on a 10cm-wide board that is raised about 4cm off the ground.
|
Baseline and again once intervention is completed (8 weeks)
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Walking speed
Time Frame: Baseline and again once intervention is completed (8 weeks)
|
Walking speed will be assessed by the time needed to walk an 80 m course at a fast pace.
|
Baseline and again once intervention is completed (8 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Darren G Candow, PhD, Professor, Associate Dean of Graduate Studies
Publications and helpful links
General Publications
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Candow DG, Little JP, Chilibeck PD, Abeysekara S, Zello GA, Kazachkov M, Cornish SM, Yu PH. Low-dose creatine combined with protein during resistance training in older men. Med Sci Sports Exerc. 2008 Sep;40(9):1645-52. doi: 10.1249/MSS.0b013e318176b310.
- Chilibeck PD, Stride D, Farthing JP, Burke DG. Effect of creatine ingestion after exercise on muscle thickness in males and females. Med Sci Sports Exerc. 2004 Oct;36(10):1781-8. doi: 10.1249/01.mss.0000142301.70419.c6.
- Harris RC, Soderlund K, Hultman E. Elevation of creatine in resting and exercised muscle of normal subjects by creatine supplementation. Clin Sci (Lond). 1992 Sep;83(3):367-74. doi: 10.1042/cs0830367.
- Nogueira W, Gentil P, Mello SN, Oliveira RJ, Bezerra AJ, Bottaro M. Effects of power training on muscle thickness of older men. Int J Sports Med. 2009 Mar;30(3):200-4. doi: 10.1055/s-0028-1104584. Epub 2009 Feb 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- URegina
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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