N/A
N=44
Immune Function and Muscle Adaptations to Resistance Exercise in Older Adults
Sarcopenia · Aging · Immune Function
Bottom Line
View on ClinicalTrials.gov: NCT02261961 ↗Enrolled (actual)
44
Serious AEs
25.0%
Results posted
Sep 2021
Primary outcome: Primary: Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine) — 63.1; 63.2 units per ml — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TDAP (Biological); Acute Resistance Exercise (Other); Resistance Exercise Training (Other); Post-training Follow-up (Other); Nutritional Supplement (Muscle Armor) (Dietary_supplement); Placebo (Kool-Aid) (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Concentration of Antibodies to Pertussis Antigen (1 Week Post-vaccine) |
63.1; 63.2 | >0.05 |
| PRIMARY Change in Plasma Concentration of Antibodies to Pertussis Antigen (2 Weeks Post-vaccine) |
159.2; 216.7 | >0.05 |
| PRIMARY Change in Plasma Concentration of C-Reactive Protein |
0.34; -3.96 | — |
| PRIMARY Change in the Number of Muscle Macrophages Per Myofiber (Pre- to Post-acute Exercise) |
16.01; -8.54 | — |
| PRIMARY Change in Muscle Strength After Exercise Training for 12 Weeks |
195.4; 182.9 | >0.05 |
| SECONDARY Change in Plasma Concentration of Antibodies to Tetanus Antigen (1 Week Post-vaccine) |
5.6; 4.1 | >0.05 |
| SECONDARY Change in Plasma Concentration of Antibodies to Tetanus Antigen (2 Weeks Post-vaccine) |
8.6; 8.2 | >0.05 |
| SECONDARY Change in Plasma Concentration of Antibodies to Diptheria Antigen (1 Week Post-vaccine) |
1.1; 1.1 | >0.05 |
| SECONDARY Change in Plasma Concentration of Antibodies to Diptheria Antigen (2 Weeks Post-vaccine) |
2.1; 1.7 | >0.05 |
| SECONDARY Number of Muscle Macrophages Per Myofiber (Resting) |
6.89; 42.42 | — |
| SECONDARY Change in Muscle Size After Exercise Training for 12 Weeks |
155.8; 146.4 | >0.05 |
| SECONDARY Change in Muscle Strength at Week 16 of the Post-Training Period |
175.5; 162.9 | >0.05 |
| SECONDARY Change in Balance After Exercise Training for 12 Weeks |
0.54; 0.79 | — |
| SECONDARY Change in Balance During the Post-Training Period at 26 Weeks of the Post-training Period |
0.08; 0.05 | — |
| SECONDARY Change in Balance at Week 16 of the Post-Training Period |
-0.08; 0.11 | — |
| SECONDARY Change in Walking Ability After Exercise Training for 12 Weeks |
18.03; 22.25 | — |
| SECONDARY Change in Walking Ability at Week 16 of the Post-Training Period |
-13.62; -29.02 | — |
| SECONDARY Change in Walking Ability at Week 26 of the Post-Training Period |
1.34; -20.85 | — |
| SECONDARY Change in Gait Speed After Exercise Training for 12 Weeks |
0.04; 0.05 | — |
| SECONDARY Change in Gait Speed at Week 16 of the Post-Training Period |
-0.02; -0.03 | — |
| SECONDARY Change in Gait Speed During at Week 26 of the Post-Training Period |
0.04; 0.03 | — |
| SECONDARY Change in Muscle Size at Week 26 of the Post-Training Period |
143.6; 140.5 | >0.05 |
| SECONDARY Change in Timed Up and Go After Exercise Training for 12 Weeks |
-0.22; -0.26 | — |
| SECONDARY Change in Timed Up and Go at Week 16 of the Post-Training Period |
0.33; 0.18 | — |
| SECONDARY Change in Timed Up and Go at Week 26 of the Post-Training Period |
0.14; -0.15 | — |
| SECONDARY Percent Change in Resting Muscle Concentration of Interleukin-1 Beta |
58.00; 40.93 | — |
| SECONDARY Change in Muscle Concentration of Interleukin-1 Beta (Pre- to Post-acute Exercise) |
110.52; -89.70 | — |
| SECONDARY Change in Resting Muscle Atrophy Gene MURF Expression |
20.98; 148.17 | — |
| SECONDARY Change in Resting Muscle Atrophy Gene MURF Expression (Post-acute Exercise) |
38.69; -76.98 | — |
| SECONDARY Change in Resting Muscle Protein Kinase B |
78.15; 51.24 | — |
| SECONDARY Change in Muscle Protein Kinase B (Post-acute Exercise) |
-27.24; 9.48 | — |
| SECONDARY Change in Number of Muscle Satellite Cells After Exercise Training for 12 Weeks |
18.24; 9.96 | — |
| SECONDARY Change in Number of Myonuclei After Exercise Training for 12 Weeks |
6.88; 20.28 | — |
| SECONDARY Change in Muscle Fiber Size After Exercise Training for 12 Weeks |
35.26; 47.28 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Veteran
- Age 60-80 years
- Body Mass Index of 18.5 - 29.9 kg/m2
Exclusion Criteria
- 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)
- Unstable abdominal or thoracic aortic aneurysm (>4cm)
- Renal disease requiring dialysis
- Allergic to vaccination
- Acute retinal hemorrhage or ophthalmologic surgery in past 3 months
- Bone fractures in the pelvis, legs, or feet in the last 3 months
- Hernia that causes pain during physical activity
- Myocardial infarction or cardiac surgery in past 3 months
- Pulmonary embolism or deep venous thrombosis in past 3 months
- Proliferative diabetic retinopathy or severe nonproliferative retinopathy
- Active suicidality or suicidal ideation
- Systemic bacterial infection
- Taking aspirin in any form and unable/unwilling to discontinue at least 10 days prior to muscle biopsy
- Unwilling to halt concurrent use of amino acid or protein supplements
- Unwilling to halt new use of nutritional supplements
- Unwilling to maintain current normal diet
- Encephalopathy in past 7 days
- Active oral or genital herpes
- Current use of appetite stimulants
- Current treatment for mania or bipolar disorder or taking lithium.
- Diagnosis of a significant cognitive deficit
- Untreated severe aortic stenosis
- Uncontrolled diabetes mellitus (HbA1C>10)
- Uncontrolled hypertension or hypotension (>160/100, <100 systolic)
- Uncontrolled malignant cardiac arrhythmia
- Unstable angina
- Allergic to latex or tape
- Bleeding or clotting disorders
- Taking any non-ASA NSAID and unable or unwilling to discontinue use for 3 days prior to muscle biopsy
- Taking Fish Oil, Gingko, Garlic, Saw Palmetto, Turmeric, or Vitamin E and unable or unwilling to discontinue use for 10 days prior to the muscle biopsy procedure
- Significant problems with chronic pain
- Uncontrolled asthma or allergies
- Taking lactulose, nitrates plus hypertension medications or Viagra
- Liver cirrhosis or other severe liver disease
- History of peripheral artery disease
- Certain Steroid or androgen use in past 3 months
- Other physician judgment
- Significantly abnormal complete blood count (CBC) or prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)
Data sourced from ClinicalTrials.gov (NCT02261961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.