NCT04266678

Brief Summary

The purpose of this study will be to evaluate whether dumbbell resistance training (DBRT) or elastic band resistance training (EBRT) is beneficial in older adults whom may be classified as sarcopenic based on the collective operational definition and older adults that do not meet the criteria to be considered sarcopenic compared to non-exercise controls of these populations after sarcopenia criteria have been established. As well as identify if resistance exercise will improve muscle quality in older adults, considering how muscle quality relates to sarcopenia status. Specific Aim 1 will determine if short-term resistance training will alter muscle quality or sarcopenia status in older adults compared to non-exercise controls. The study team will instruct and supervise adults aged 55-85 in structured, periodized EBRT or DBRT for 6 weeks. After the training, muscle quality and sarcopenia status will be re-evaluated. It is hypothesized that both types of training (EBRT and DBRT) will improve the sarcopenia status of older adults engaging in resistance training and if sarcopenic, their classification may change to non-sarcopenic. A secondary hypothesis is that EBRT will be more beneficial than DBRT, resulting in greater changes in body composition, strength, and functional movements. It is also hypothesized that muscle quality, as an index of relative strength, will improve after 6 weeks of resistance training with either dumbbells or elastic bands and that there is a strong negative linear relationship between severity of sarcopenia and muscle quality. Specific Aim 2 will evaluate the prevalence of sarcopenia in older adults using previously-identified equations and cut-off values and to subsequently generate a new index to include functional muscle mass and performance to identify sarcopenic individuals. This will be completed using muscle mass estimations from dual-energy x-ray absorptiometry (DEXA), bioelectrical impedance analysis (BIA), functional performance measures, and structural composition. It is hypothesized that DEXA and BIA will provide accurate estimates of appendicular lean mass (ALM), and functional performance (handgrip strength and gait speed) will be significant contributors to a predictive equation of a muscle quality index for men and women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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 9, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

February 10, 2020

Last Update Submit

April 26, 2021

Conditions

Keywords

muscular strengthfunctional capacityresistance exercise

Outcome Measures

Primary Outcomes (2)

  • Muscle mass

    Quantity of upper and lower body muscle mass with DXA (in kg)

    6-weeks

  • Upper and lower body strength

    Maximal amount of weight lifted in 5 repetitions for bench press and leg press

    6-weeks

Secondary Outcomes (3)

  • Fat mass

    6-weeks

  • Short Physical Performance Battery (SPPB)

    6-weeks

  • Handgrip Strength

    6-weeks

Study Arms (3)

Elastic band resistance training

EXPERIMENTAL

Resistance training with elastic resistance bands two days per week for 6-weeks.

Behavioral: Resistance exercise program

Dumbbell resistance training

ACTIVE COMPARATOR

Resistance training with dumbbell weights two days per week for 6-weeks.

Behavioral: Resistance exercise program

Non-exercise Control

NO INTERVENTION

Education and guidance for exercise recommendations in older adults but no active training sessions.

Interventions

Exercise sessions with exercise science professional. Target hypertrophy repetition range and progressive resistance exercise.

Also known as: control-no exercise
Dumbbell resistance trainingElastic band resistance training

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has provided written and dated informed consent to participate in the study.
  • Subject is a male or female between 55 and 85 years of age, inclusive.
  • Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
  • Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).

You may not qualify if:

  • Subject has a history of alcohol or other drug abuse in the past year.
  • Subject has a history or current presence of congestive heart failure, or any other form of cardiovascular disease that might put the subject at risk.
  • Subject has a significant history or current presence of untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) \[systolic BP\> 140 and/or diastolic BP\> 90\], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
  • Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s) that might put the subject at risk and/or confound the results of the study.
  • Subject has a history of orthopedic injury or surgery within the last year that may prevent them from completing the study procedures.
  • Subject has arthritis of the hand which could impair his/her ability to grip a dynamometer.
  • Subject has severe arthritis defined as grade 3 or higher as diagnosed by a physician.
  • No history of CT scans (computed tomography), PET and nuclear medicine studies, or fluoroscopic procedures within the past year. Nuclear medicine imaging studies use agents that will interfere with the DXA whole body scan.
  • No implants, hardware, devices, or other foreign material in the measurement area. These devices will make whole body measurements difficult to interpret when the devices or implants are located within the scan field.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas-Edwards Campus; Exercise and Human Performance Laboratory

Overland Park, Kansas, 66213, United States

Location

Related Publications (9)

  • Baumgartner RN, Wayne SJ, Waters DL, Janssen I, Gallagher D, Morley JE. Sarcopenic obesity predicts instrumental activities of daily living disability in the elderly. Obes Res. 2004 Dec;12(12):1995-2004. doi: 10.1038/oby.2004.250.

    PMID: 15687401BACKGROUND
  • Bergquist R, Iversen VM, Mork PJ, Fimland MS. Muscle Activity in Upper-Body Single-Joint Resistance Exercises with Elastic Resistance Bands vs. Free Weights. J Hum Kinet. 2018 Mar 23;61:5-13. doi: 10.1515/hukin-2017-0137. eCollection 2018 Mar.

    PMID: 29599855BACKGROUND
  • Calatayud J, Borreani S, Colado JC, Martin F, Rogers ME. Muscle activity levels in upper-body push exercises with different loads and stability conditions. Phys Sportsmed. 2014 Nov;42(4):106-19. doi: 10.3810/psm.2014.11.2097.

    PMID: 25419894BACKGROUND
  • Copeland JL, Good J, Dogra S. Strength training is associated with better functional fitness and perceived healthy aging among physically active older adults: a cross-sectional analysis of the Canadian Longitudinal Study on Aging. Aging Clin Exp Res. 2019 Sep;31(9):1257-1263. doi: 10.1007/s40520-018-1079-6. Epub 2018 Nov 27.

    PMID: 30484254BACKGROUND
  • Nilwik R, Snijders T, Leenders M, Groen BB, van Kranenburg J, Verdijk LB, van Loon LJ. The decline in skeletal muscle mass with aging is mainly attributed to a reduction in type II muscle fiber size. Exp Gerontol. 2013 May;48(5):492-8. doi: 10.1016/j.exger.2013.02.012. Epub 2013 Feb 17.

    PMID: 23425621BACKGROUND
  • Schrack JA, Zipunnikov V, Simonsick EM, Studenski S, Ferrucci L. Rising Energetic Cost of Walking Predicts Gait Speed Decline With Aging. J Gerontol A Biol Sci Med Sci. 2016 Jul;71(7):947-53. doi: 10.1093/gerona/glw002. Epub 2016 Feb 5.

    PMID: 26850913BACKGROUND
  • Skelton DA, Greig CA, Davies JM, Young A. Strength, power and related functional ability of healthy people aged 65-89 years. Age Ageing. 1994 Sep;23(5):371-7. doi: 10.1093/ageing/23.5.371.

    PMID: 7825481BACKGROUND
  • Snijders T, Nederveen JP, Bell KE, Lau SW, Mazara N, Kumbhare DA, Phillips SM, Parise G. Prolonged exercise training improves the acute type II muscle fibre satellite cell response in healthy older men. J Physiol. 2019 Jan;597(1):105-119. doi: 10.1113/JP276260. Epub 2018 Nov 24.

    PMID: 30370532BACKGROUND
  • Yoshiko A, Tomita A, Ando R, Ogawa M, Kondo S, Saito A, Tanaka NI, Koike T, Oshida Y, Akima H. Effects of 10-week walking and walking with home-based resistance training on muscle quality, muscle size, and physical functional tests in healthy older individuals. Eur Rev Aging Phys Act. 2018 Nov 19;15:13. doi: 10.1186/s11556-018-0201-2. eCollection 2018.

    PMID: 30473735BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Ashley A Herda, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

April 9, 2019

Primary Completion

March 16, 2020

Study Completion

October 30, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations