Short- and long-term effects of progressive resistance exercise on muscle and bone mass, physical and mental performance and balance compared to age-matched non-exercising middle-aged and older adults
| ISRCTN | ISRCTN87134571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87134571 |
- Submission date
- 17/02/2023
- Registration date
- 02/03/2023
- Last edited
- 02/03/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Aging results in the loss of muscle, bone, strength, physical and mental performance, endurance, flexibility, and balance. These changes also affect one's ability to function in everyday life (for instance, to do yard work, or buy and transport groceries). Abundant research evidence demonstrates that, regardless of age, many of the harmful physical and mental of aging can be reduced, prevented, or even reversed with exercise. However, there are few multi-year experimental exercise studies in middle-aged and older adults. The current study investigates the short and long-term effects of progressive resistance exercise on muscle and bone mass, physical and mental function, and balance in aging.
Who can participate?
People over the age of 40 years who are committed to completing a monitored exercise program three times per week
What does the study involve?
Participants self-select into an experimental exercise or control non-exercising group. Physical function, cognitive performance, and balance data are collected every 14 weeks, and muscle and bone mass data are collected at the start of the study and after 42 weeks. Participants in the experimental group exercise three times per week. Once they complete the 42-week exercise program, they complete the cycle again with heavier loads. This pattern is completed as long as they stay enrolled in the study.
What are the possible benefits and risks of participation?
There is a small risk of injury, muscle soreness or cramping, acute cardiovascular event, bruising, low blood sugar, motion sickness from VR cognitive testing, exposure to infectious disease, and radiation exposure (equal to living one day of life in Denver, CO). Overall, these risks are similar to any individual who exercises, though they might be mitigated due to the constant monitoring of the exercise by the research investigators. Participants in the experimental group are expected to benefit by accruing new or maintaining current muscle and bone mass, improving or preserving physical and cognitive performance, and improving balance. Participants in the control group will benefit from the comprehensive assessments.
Where is the study run from?
University of Houston - Clear Lake (USA)
When is the study starting and how long is it expected to run for?
August 2021 to August 2033
Who is funding the study?
University of Houston - Clear Lake (USA)
Who is the main contact?
Dr William E. Amonette, amonette@uhcl.edu
Contact information
Principal Investigator
2700 Bay Area BLVD
Houston
77058
United States of America
 ORCID ID |
0000-0002-6074-3573 |
|---|---|
| Phone | +1 (0)281 283 3381 |
| amonette@uhcl.edu |
Study information
| Study design | Non-randomized controlled trial (between-within design) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | University/medical school/dental school |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Longitudinal study of aging, health, and human performance: the skeletal muscle matters protocol |
| Study objectives | Middle-aged and older adults engaging in long-term progressive resistance exercise will experience reduced muscle loss, less falls, improved cognition, balance and functional performance compared to age-matched controls who do not engage in formal strength training. |
| Ethics approval(s) | Approved 20/10/2021, the Committee for the Protection of Human Subjects at the University of Houston - Clear Lake (Bayou Building, 2531, 2700 Bay Area Blvd, Box 44, Houston, TX, 77058-1002, USA; +1 (0)281 283 3015; Sponsoredprograms@uhcl.edu), ref: 02-22-003 |
| Health condition(s) or problem(s) studied | Aging and skeletal muscle loss |
| Intervention | Participants self-select into an experimental exercise or control non-exercising group. Physical function, cognitive performance, and balance data are collected every 14 weeks, and muscle and bone mass data are collected at the start of the study and after 42 weeks. Participants in the experimental group exercise three times per week. Once they complete the 42-week exercise program, they complete the cycle again with heavier loads. This pattern is completed as long as they stay enrolled in the study. |
| Intervention type | Other |
| Primary outcome measure | Skeletal muscle mass and bone mineral density measured with dual x-ray absorptiometry every 42 weeks |
| Secondary outcome measures | 1. Force and power output measured with force plates during the sit-to-stand test every 14 weeks 2. Total time to complete the Timed-up-and-go test measured every 14 weeks 3. Time to complete and number of steps measured in the forward 10-meter walk test performed every 14 weeks 4. Time to complete and number of steps measured in the backward 10-meter walk test performed every 14 weeks 5. Sway magnitude measured with a computerized dynamic posturography device during a sensory organization text every 14 weeks 6. Total distance walked during the 6-minute walk test completed every 14 weeks 7. Cognitive function measured with Bell’s test, mini-cognitive assessment, Trails A&B, the Digit-Symbol, and Navigation measured every 14 weeks 8. Daily workout volume-load measured using the weight lifted multiplied by the sets and repetitions 9. The number of falls documented monthly 10. Blood pressure measured monthly with a sphygmomanometer 11. Body weight measured monthly with a digital scale |
| Overall study start date | 01/08/2021 |
| Completion date | 01/08/2033 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | 1. At least 40 years of age 2. Have the ability to perform lower- and upper-body exercises 3. Commit to exercise 2-3 times per week (experimental group only) 4. Free from overt neurologic disease or injury |
| Key exclusion criteria | Overt neurologic disease or inability to ambulate safely without assistance |
| Date of first enrolment | 15/01/2022 |
| Date of final enrolment | 15/01/2032 |
Locations
Countries of recruitment
- United States of America
Study participating centre
2700 Bay Area Blvd
Houston
77058
United States of America
Sponsor information
University/education
Office of Sponsored Research
cc: Erin Noel Haynes
University of Houston – Clear Lake
2700 Bay Area Blvd
Houston
77058
United States of America
| Phone | +1 (0)281 283 3019 |
|---|---|
| amonette@uhcl.edu | |
| Website | https://www.uhcl.edu/hhpi/ |
"ROR" |
https://ror.org/01t817z14 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Houston, UH
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/10/2032 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Short-term data will be published when a sufficient number of participants have completed 42 weeks of exercise (one full cycle). Long-term data will be published at the 2, 5, and 10-year mark with sufficient data. |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the results publication. Upon signing the Informed Consent form approved by the Committee for the Protection of Human Subjects at the University of Houston - Clear Lake, each subject will be assigned a number from 1 –500. All data will be catalogued and stored with the use of this number. Data will be kept in a locked office, in a locked file cabinet, or on a password-protected computer in a password protected file. Only the principal investigator and co-investigators will have access to these data during the experiment. Every effort will be made to maintain the confidentiality of the study records. The data collected from the study will be used for educational and publication purposes. However, the data will be maintained such that no data will be linked to an individual. In the event that any publications result from this evaluation, no personally identifiable information will be disclosed without prior consent. For federal audit purposes, subjects’ documentation for this research project will be maintained and safeguarded by the principal investigator for a minimum of three years after completion of the study. After that time, the subjects’ documentation may be destroyed. |
Editorial Notes
02/03/2023: Trial's existence confirmed by the Committee for the Protection of Human Subjects at the University of Houston - Clear Lake.
