Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults

NCT02261961 | Completed Results

• 3 other identifiers: E1203-RRX001203608119
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The loss of muscle mass and strength due to aging leads to serious health problems for older adults. Muscle health can be improved by exercise training, but some people improve their strength substantially, whereas others improve little. The reason for this variation is unknown. This study will investigate whether function of the immune system influences how well people respond to exercise. Older Veterans who participate will have their muscle size, strength, and function measured periodically for almost a year. Participants will drink a nutritional supplement or placebo daily and complete a 36 session strength training program. Participants will be vaccinated for tetanus and donate small amounts of blood and muscle tissue during the study so that immune function can be compared to muscle outcomes during training and during a long-term follow-up. The study results should increase the investigators' understanding of the negative effects of aging on muscle and will possibly lead to better strategies for muscle maintenance and rehabilitation for older adults.

Conditions

Sarcopenia; Aging; Immune Function

Keywords

resistance exercise; Juven; exercise training; interleukin-1; insulin-like growth factor

Outcome Measures

Primary Outcomes (5)

• Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine)

  The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and one week post-vaccination.

  change from baseline at 1 week post-vaccine

• Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine)

  The change in plasma antibody concentration for response to the pertussis antigen within the tetanus, diphtheria, and pertussis (TDAP) vaccination will be measured between baseline and two weeks post-vaccination.

  change from baseline at 2 weeks post-vaccine

• Change in Plasma Concentration of C-Reactive Protein

  Plasma c-reactive protein will be measured before and after two weeks of treatment with supplement or placebo.

  change from baseline at 2 weeks of treatment

• Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise)

  The change in the number of muscle macrophages per myofiber will be calculated for muscle collected before and 72 hours after a single bout of resistance exercise. The changes in macrophage numbers before and after two weeks of treatment with supplement or placebo will be compared.

  change from baseline at 2 weeks of treatment

• Change in Muscle Strength After Exercise Training for 12 Weeks

  The change in muscle strength after exercise training will be measured as the difference in one-repetition maximum capability for knee extension from before and after completion of the exercise training program.

  change from baseline at completion of exercise training phase (12 weeks)

Secondary Outcomes (29)

• Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine)

  change from baseline at 1 week post-vaccine

• Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine)

  change from baseline at 2 weeks post-vaccine

• Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine)

  change from baseline at 1 week post-vaccine

• Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine)

  change from baseline at 2 weeks post-vaccine

• Number of Muscle Macrophages Per Myofiber (Resting)

  change from baseline at 2 weeks of treatment

Other Outcomes (10)

• Plasma Concentration of Aspartate Aminotransferase After Product Consumption for 15 Weeks

  at completion of the exercise training program (15 weeks)

• Plasma Concentration of Alanine Aminotransferase After Product Consumption for 15 Weeks

  completion of the exercise training program (15 weeks)

• Ratio of Plasma Concentrations of Blood Urea Nitrogen to Creatinine After Product Consumption for 15 Weeks

  completion of the exercise training program (15 weeks)

Study Arms (2)

Nutritional Supplement

EXPERIMENTAL

Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.

Biological: TDAP; Other: Acute Resistance Exercise; Other: Resistance Exercise Training; Other: Post-training Follow-up; Dietary Supplement: Nutritional Supplement (Muscle Armor)

Placebo

PLACEBO COMPARATOR

Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.

Biological: TDAP; Other: Acute Resistance Exercise; Other: Resistance Exercise Training; Other: Post-training Follow-up; Dietary Supplement: Placebo (Kool-Aid)

Interventions

TDAP BIOLOGICAL

Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo

Also known as: tetanus, diptheria, and pertussis vaccination

Nutritional Supplement; Placebo

Acute Resistance Exercise OTHER

Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle

Also known as: Single bout of exercise

Nutritional Supplement; Placebo

Resistance Exercise Training OTHER

Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.

Also known as: Chronic exercise

Nutritional Supplement; Placebo

Post-training Follow-up OTHER

Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.

Also known as: Detraining Period

Nutritional Supplement; Placebo

Nutritional Supplement (Muscle Armor) DIETARY_SUPPLEMENT

Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.

Nutritional Supplement

Placebo (Kool-Aid) DIETARY_SUPPLEMENT

Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• Age 60-80 years
• Body Mass Index of 18.5 - 29.9 kg/m2

You may not qualify if:

• Currently participating in any other research study involving an intervention
• Smokes tobacco products
• Tetanus or TDAP vaccine in previous two years
• Allergic to vaccination
• Seizure in past 3 months
• Guillain-Barre Syndrome in past 3 months
• Takes the medications heparin, plavix / clopidogrel, or coumadin / warfarin
• Allergic to lidocaine
• Significant problem with fainting
• Problems walking or exercising with both legs
• Participated in a weight-lifting program targeting the thighs in last 3 months
• Pains, tightness or pressure in chest during physical activity
• Metastatic cancer or undergoing chemotherapy
• Cerebral aneurysm or intracranial bleed in past year
• End-stage congestive heart failure (NYHA Stage IV)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Arkansas: collaborator

Study Sites (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, 72114-1706, United States

Location

Related Publications (4)

• Long DE, Villasante Tezanos AG, Wise JN, Kern PA, Bamman MM, Peterson CA, Dennis RA. A guide for using NIH Image J for single slice cross-sectional area and composition analysis of the thigh from computed tomography. PLoS One. 2019 Feb 7;14(2):e0211629. doi: 10.1371/journal.pone.0211629. eCollection 2019.

  PMID: 30730923 BACKGROUND

• Dennis RA, Long DE, Landes RD, Padala KP, Padala PR, Garner KK, Wise JN, Peterson CA, Sullivan DH. Tutorial for using SliceOmatic to calculate thigh area and composition from computed tomography images from older adults. PLoS One. 2018 Oct 2;13(10):e0204529. doi: 10.1371/journal.pone.0204529. eCollection 2018.

  PMID: 30278056 RESULT

• Kosmac K, Peck BD, Walton RG, Mula J, Kern PA, Bamman MM, Dennis RA, Jacobs CA, Lattermann C, Johnson DL, Peterson CA. Immunohistochemical Identification of Human Skeletal Muscle Macrophages. Bio Protoc. 2018 Jun 20;8(12):e2883. doi: 10.21769/BioProtoc.2883.

  PMID: 30148186 RESULT

• Dennis RA, Ponnappan U, Kodell RL, Garner KK, Parkes CM, Bopp MM, Padala KP, Peterson CA, Padala PR, Sullivan DH. Immune Function and Muscle Adaptations to Resistance exercise in Older Adults: Study Protocol for a Randomized Controlled Trial of a Nutritional Supplement. Trials. 2015 Mar 27;16:121. doi: 10.1186/s13063-015-0631-3.

  PMID: 25872570 RESULT

MeSH Terms

Conditions

Sarcopenia

Interventions

Tetanus Toxoid; Resistance Training; Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Richard Dennis
• Organization: Central Arkansas Veterans Healthcare System

richard.dennis2@va.gov

501-257-5583

Study Officials

• Richard A Dennis, PhD

  Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: October 10, 2014
• Study Start: July 23, 2014
• Primary Completion: December 31, 2018
• Study Completion: September 30, 2019
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)