Sedentary Lifestyle Clinical Trial
— MU-SSSHOfficial title:
Physical Function in Older Adults in the Stay Strong, Stay Healthy Program
NCT number | NCT03990415 |
Other study ID # | 2014256 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2019 |
Est. completion date | December 31, 2019 |
Verified date | March 2021 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The University of Missouri's Stay Strong, Stay Healthy (SSSH) program is an eight week strength training class for older adults. Exercise training programs, like SSSH, can increase muscle mass and strength, improve bone density and reduce the risk of osteoporosis and related fractures, improve diabetes, heart disease, arthritis, depression, and obesity; and increase self-confidence, sleep and vitality in older adults. Specifically, the SSSH program has been shown to increase elderly individuals' confidence in their physical abilities. The primary objective of this research study is to track physiologic changes and determine the effectiveness of the SSSH exercise intervention to improve balance and fall risk in older adults. Participant's balance, gait, muscle strength, body composition, and skeletal health will be compared to a walking group and to a sedentary control group prior to and immediately following the eight week exercise intervention. After the intervention period participants will have the opportunity to participate in an interview process to further discuss their experiences and perceptions regarding the intervention and their health.
Status | Completed |
Enrollment | 52 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 100 Years |
Eligibility | Inclusion Criteria: - Are male or female =60 years of age - Are sedentary (no strength training and <30min/wk of other physical activity in the past 3 months) - Are ambulatory (cane or walker permitted) - Are free from current physical injury or illness preventing physical activity Exclusion Criteria: - Answered YES to two or more questions on the PAR-Q form - Are female subjects who have not fully gone through menopause - Were a previous SSSH participant - Have dementia/Alzheimer's or other cognitive impairments that would limit ability to follow directions |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
Dana Duren |
United States,
Ball S, Gammon R, Kelly PJ, Cheng AL, Chertoff K, Kaume L, Abreu EL, Brotto M. Outcomes of Stay Strong, Stay Healthy in community settings. J Aging Health. 2013 Dec;25(8):1388-97. doi: 10.1177/0898264313507318. Epub 2013 Oct 22. — View Citation
Beavers KM, Walkup MP, Weaver AA, Lenchik L, Kritchevsky SB, Nicklas BJ, Ambrosius WT, Stitzel JD, Register TC, Shapses SA, Marsh AP, Rejeski WJ. Effect of Exercise Modality During Weight Loss on Bone Health in Older Adults With Obesity and Cardiovascular Disease or Metabolic Syndrome: A Randomized Controlled Trial. J Bone Miner Res. 2018 Dec;33(12):2140-2149. doi: 10.1002/jbmr.3555. Epub 2018 Aug 7. — View Citation
Crowe EM, Ball SD. Effectiveness of Advanced Stay Strong, Stay Healthy in Community Settings. Gerontol Geriatr Med. 2015 Aug 3;1:2333721415596462. doi: 10.1177/2333721415596462. eCollection 2015 Jan-Dec. — View Citation
Foster C, Armstrong MEG. What types of physical activities are effective in developing muscle and bone strength and balance? J Frailty Sarcopenia Falls. 2018 Jun 1;3(2):58-65. doi: 10.22540/JFSF-03-058. eCollection 2018 Jun. Review. — View Citation
Guizelini PC, de Aguiar RA, Denadai BS, Caputo F, Greco CC. Effect of resistance training on muscle strength and rate of force development in healthy older adults: A systematic review and meta-analysis. Exp Gerontol. 2018 Feb;102:51-58. doi: 10.1016/j.exger.2017.11.020. Epub 2017 Nov 28. — View Citation
Northey JM, Cherbuin N, Pumpa KL, Smee DJ, Rattray B. Exercise interventions for cognitive function in adults older than 50: a systematic review with meta-analysis. Br J Sports Med. 2018 Feb;52(3):154-160. doi: 10.1136/bjsports-2016-096587. Epub 2017 Apr 24. Review. — View Citation
Seguin RA, Economos CD, Hyatt R, Palombo R, Reed PN, Nelson ME. Design and national dissemination of the StrongWomen Community Strength Training Program. Prev Chronic Dis. 2008 Jan;5(1):A25. Epub 2007 Dec 15. Erratum in: Prev Chronic Dis. 2008 Apr;5(2):A71. — View Citation
Seguin RA, Folta SC, Nelson ME, Hanson KL, LaCroix AZ. Long-Term Body Weight Maintenance among StrongWomen-Healthy Hearts Program Participants. J Environ Public Health. 2017;2017:4372048. doi: 10.1155/2017/4372048. Epub 2017 Mar 2. — View Citation
Syed-Abdul, M.M., Peterson, E.C., Mills-Gray, S.L., Parks, E.J. & Ball, S.D. Stay Strong, Stay Healthy: University of Missouri-Extension's Strength-Training Program for Older Adults in Community Settings. Med Sci Sports Exer 48:5, 125-125 (2016).
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Balance During a Dynamic Task Using Force Plates. | Participants will complete the 30 second sit-to-stand dynamic balance task on two force plates, which will allow for a sensitive measure of balance. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Primary | Change in Balance During a Static Task Using Force Plates. | Participants will complete the CDC 4 stance static balance task on force plates, allowing for a more sensitive measure of balance. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Grip Strength Using a Hand Dynamometer. | Participants will test their grip strength using a hand dynamometer over time. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Walking Speed Using a 10 Meter Course. | Participants will walk a self selected pace over a 10 meter distance and the investigators will time this process before and after the intervention. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in the Timed Up and Go | Investigators will test the change in participant's timed up and go (TUG) performance. This is the TUG that covers an 8 foot distance. The pre and post measure will be used to calculate a percent change, with positive values indicating a decline in performance and a negative value indicating an improvement in performance times. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Upper Body Muscle Flexibility Using the Back Scratch Test. | Investigators will test the change in participant's upper body flexibility by using the back scratch test. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Lower Body Muscle Flexibility Using the Sit and Reach Test. | Investigators will test the change in participant's lower body flexibility by using the sit and reach test. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Sleep Quality Using the Pittsburgh Sleep Quality Index Test. | Participants will complete the Pittsburgh Sleep Quality Index Test. The pre and post measure will be used to calculate a percent change, with positive values indicating an increase and a negative value indicating a decline which is good. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Cognition Performance Using the Self Administered Gerocognitive Examination. | Participants will complete the Self Administered Gerocognitive Examination. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes in Bone Activity Using the Ratio of Serum Bone Turnover Markers (PINP ng/mL and CTX ng/mL). | We will test the change in bone activity by using blood samples to measure markers of bone formation (PINP) and bone resorption (CTX). The percent change in the ratio will allow us to see the extent of bone resorption occurring with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. | |
Secondary | Changes is Bone Mineral Density T-scores | aBMD measures of bone mineral density and their associated t-scores from the DXA. The pre and post measure will be used to calculate a percent change, with positive values indicating an improvement and a negative value indicating a decline. | Baseline and at end of intervention period, typically 8 weeks. |
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