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Short-Term Resistance Training in Older Adults (OART)

Primary Purpose

Sarcopenia, Muscle Quality

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise program
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring muscular strength, functional capacity, resistance exercise

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Elastic band resistance training

Dumbbell resistance training

Non-exercise Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Muscle mass
Quantity of upper and lower body muscle mass with DXA (in kg)
Upper and lower body strength
Maximal amount of weight lifted in 5 repetitions for bench press and leg press

Secondary Outcome Measures

Fat mass
Quantity of fat assessed by DXA
Short Physical Performance Battery (SPPB)
gait speed and balance tests
Handgrip Strength
maximal dominant hand handgrip strength (in kg)

Full Information

First Posted
February 10, 2020
Last Updated
April 26, 2021
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT04266678
Brief Title
Short-Term Resistance Training in Older Adults
Acronym
OART
Official Title
Changes to Muscle Quality and Sarcopenia Status After Short-Term Resistance Training in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
It is well known that as adults age, a proportion of lean body mass is reduced if not lost, specifically fast twitch (FT or Type II) fibers, and subsequently, strength and power is diminished. The age-related loss of muscle mass and function is referred to as sarcopenia. Reduction of muscle mass plays a direct role in the loss of function, and potentially, the ability to complete activities of daily living. It is also highly related to an increase in incidence of falls and onset of many other comorbidities resulting in changes in quality of life (QOL). Copeland et al. recently reported that strength training will benefit all adults, regardless of their functional level, based on a self-report survey of nearly 10,000 adults aged 60 years and older. Aside from diagnosing sarcopenia in individuals using pre-identified criteria (and doing so accurately), it is of the utmost importance to implement resistance exercise programs in populations of older adults that can directly combat the decline in type II fiber size, maintain aerobic fitness, aid in maintaining or reducing total body fat, minimize the prevalence of sarcopenia, and ultimately improve QOL. Targeted interventions that include dumbbell and elastic band resistance training (both considered free-movement) and progressive programming schemes have been reported to enhance muscle size, strength, and quality, functional mobility, and confidence in older adults, in turn, reducing percent body fat, risk of falls, and incidence of comorbidities that are often coupled with senescence. Recently, Calatayud et al. reported similar improvements in strength and muscle activation (electromyographic [EMG] amplitude) between free weight (bench press) and resistance band (band push-up) exercises, suggesting either mode of resistance exercise would be beneficial. Furthermore, use of resistance bands for chest flys and reverse flys were validated to be comparable with conventional free weights. There are several exercises that can be duplicated using either modality. However, the challenge is the vertical plane for free weights, as free weights only provide resistance against gravity and exercise movements, more specifically, body position, need to be modified in order to perform the resisted movement. Some older adults tend to have balance impairments and thus adjusting their body position to perform (dumbbell) resisted exercise may not be ideal, specifically if they may have a greater risk for falls as suggested by sarcopenia status (i.e. reduced muscle mass and gait speed or strength). Therefore 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Muscle Quality
Keywords
muscular strength, functional capacity, resistance exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elastic band resistance training
Arm Type
Experimental
Arm Description
Resistance training with elastic resistance bands two days per week for 6-weeks.
Arm Title
Dumbbell resistance training
Arm Type
Active Comparator
Arm Description
Resistance training with dumbbell weights two days per week for 6-weeks.
Arm Title
Non-exercise Control
Arm Type
No Intervention
Arm Description
Education and guidance for exercise recommendations in older adults but no active training sessions.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise program
Other Intervention Name(s)
control-no exercise
Intervention Description
Exercise sessions with exercise science professional. Target hypertrophy repetition range and progressive resistance exercise.
Primary Outcome Measure Information:
Title
Muscle mass
Description
Quantity of upper and lower body muscle mass with DXA (in kg)
Time Frame
6-weeks
Title
Upper and lower body strength
Description
Maximal amount of weight lifted in 5 repetitions for bench press and leg press
Time Frame
6-weeks
Secondary Outcome Measure Information:
Title
Fat mass
Description
Quantity of fat assessed by DXA
Time Frame
6-weeks
Title
Short Physical Performance Battery (SPPB)
Description
gait speed and balance tests
Time Frame
6-weeks
Title
Handgrip Strength
Description
maximal dominant hand handgrip strength (in kg)
Time Frame
6-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley A Herda, PhD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas-Edwards Campus; Exercise and Human Performance Laboratory
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
If required for publication, IPD will be made available through an Institution-supported database server.
Citations:
PubMed Identifier
15687401
Citation
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.
Results Reference
background
PubMed Identifier
29599855
Citation
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.
Results Reference
background
PubMed Identifier
25419894
Citation
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.
Results Reference
background
PubMed Identifier
30484254
Citation
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.
Results Reference
background
PubMed Identifier
23425621
Citation
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.
Results Reference
background
PubMed Identifier
26850913
Citation
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.
Results Reference
background
PubMed Identifier
7825481
Citation
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.
Results Reference
background
PubMed Identifier
30370532
Citation
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.
Results Reference
background
PubMed Identifier
30473735
Citation
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.
Results Reference
background

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Short-Term Resistance Training in Older Adults

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