NCT02442479

Brief Summary

Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial 5-year funding period of this award (2001-2006). In the subsequent 5-year funding period (2007-2012), the investigators built on this prior work by using a dose-response approach in older adults - ultimately to optimize the treatment of age-related muscle atrophy. The investigators tested four, long-term resistance training prescriptions in older (60-75 yr) women and men to determine which prescription maximizes mechanisms driving muscle regrowth. One of the innovations in this project was the use of a 4-wk pre-training program to reach a plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from which both mechanisms of measurable muscle hypertrophy and functional consequences of hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent experimental period. A randomized design was used to test the overarching hypothesis that a novel program of mixed strength and power training would optimize the anabolic environment to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with three specific aims.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Last Updated

April 25, 2016

Status Verified

May 1, 2015

Enrollment Period

4.9 years

First QC Date

May 6, 2015

Last Update Submit

April 21, 2016

Conditions

Keywords

exerciseresistance trainingmuscle strengthmuscle hypertrophy

Outcome Measures

Primary Outcomes (1)

  • muscle mass

    DXA-determined lean mass and thigh muscle mass

    Change from baseline at week 35

Secondary Outcomes (3)

  • vastus lateralis muscle fiber size

    Change from baseline at week 35

  • maximum strength

    Change from baseline at week 35

  • maximum power

    Change from baseline at week 35

Other Outcomes (4)

  • sit-to-stand difficulty

    Change from baseline at week 35

  • steady state exercise difficulty

    Change from baseline at week 35

  • mobility function

    Change from baseline at week 35

  • +1 more other outcomes

Study Arms (4)

HHH3

ACTIVE COMPARATOR

High-resistance concentric-eccentric training (H) 3 d/wk (HHH3).

Behavioral: resistance training

HLH3

EXPERIMENTAL

3 d/wk mixed model consisting of high-resistance concentric-eccentric training 2 d/wk separated by 1 bout of low-resistance, high-velocity, concentric only training (L) (HLH3).

Behavioral: resistance training

HH2

EXPERIMENTAL

High-resistance concentric-eccentric training 2 d/wk (HH2).

Behavioral: resistance training

HL2

EXPERIMENTAL

2 d/wk mixed model consisting of high-resistance concentric-eccentric training 1 d/wk and low-resistance, high-velocity, concentric only training 1 d/wk (HL2).

Behavioral: resistance training

Interventions

HH2HHH3HL2HLH3

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age; BMI less than or equal to 30; passed comprehensive physical examination including resting electrocardiogram and a diagnostic graded exercise stress test with 12-lead electrocardiogram; able to exercise on a treadmill for 10 minutes; (female participants) at least 5 years post-menopausal.

You may not qualify if:

  • Neurological, musculoskeletal, or other disorder that would preclude completing resistance training and all performance tests; uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia; diabetes mellitus; pregnancy; any other medical condition that would interfere with testing or increase one's risk of complications during exercise; lidocaine allergy; prescription anti-coagulants (e.g., Coumadin); current androgen or anabolic (e.g., GH, IGF-I) therapy; food allergy to cow's milk; history of regular resistance exercise during the previous 3 years; any contraindications to magnetic resonance imaging including pacemakers, aneurysm clips, or any other ferrous metal implants; current adherence to a weight reduction diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Center for Exercise Medicine

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Stec MJ, Thalacker-Mercer A, Mayhew DL, Kelly NA, Tuggle SC, Merritt EK, Brown CJ, Windham ST, Dell'Italia LJ, Bickel CS, Roberts BM, Vaughn KM, Isakova-Donahue I, Many GM, Bamman MM. Randomized, four-arm, dose-response clinical trial to optimize resistance exercise training for older adults with age-related muscle atrophy. Exp Gerontol. 2017 Dec 1;99:98-109. doi: 10.1016/j.exger.2017.09.018. Epub 2017 Sep 28.

MeSH Terms

Conditions

Muscular AtrophyMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 13, 2015

Study Start

April 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

April 25, 2016

Record last verified: 2015-05

Locations