NCT03990415

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

June 6, 2019

Results QC Date

December 3, 2020

Last Update Submit

March 2, 2021

Conditions

Keywords

ElderlyBalanceStrength Training

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (9)

  • Changes in Grip Strength Using a Hand Dynamometer.

    Baseline and at end of intervention period, typically 8 weeks.

  • Changes in Walking Speed Using a 10 Meter Course.

    Baseline and at end of intervention period, typically 8 weeks.

  • Changes in the Timed Up and Go

    Baseline and at end of intervention period, typically 8 weeks.

  • Changes in Upper Body Muscle Flexibility Using the Back Scratch Test.

    Baseline and at end of intervention period, typically 8 weeks.

  • Changes in Lower Body Muscle Flexibility Using the Sit and Reach Test.

    Baseline and at end of intervention period, typically 8 weeks.

  • +4 more secondary outcomes

Study Arms (3)

Stay Strong, Stay Healthy Group

EXPERIMENTAL

The Stay Strong, Stay Healthy strength training group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured program to learn and progress through strength training exercises designed to increase overall fitness, flexibility, and balance.

Behavioral: Exercise

Walking Group

ACTIVE COMPARATOR

The walking group will meet two times per week for an hour, for eight consecutive weeks. This class provides participants a structured walking program to help delineate the effects of the strength training program and exercise in general.

Behavioral: Exercise

Delayed Start Group

NO INTERVENTION

The delayed start group will not make any changes to their sedentary lifestyle and will be encouraged to not begin any exercise programs throughout the duration of the study.

Interventions

ExerciseBEHAVIORAL

Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults.

Stay Strong, Stay Healthy GroupWalking Group

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (10)

  • 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.

    PMID: 18082014BACKGROUND
  • 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.

    PMID: 28352287BACKGROUND
  • 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.

    PMID: 29196141BACKGROUND
  • 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.

    PMID: 32300694BACKGROUND
  • 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.

    PMID: 30088288BACKGROUND
  • 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.

    PMID: 28438770BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    PMID: 28138461BACKGROUND
  • 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.

    PMID: 24150062BACKGROUND
  • Baker BS, Weitzel KJ, Royse LA, Miller K, Guess TM, Ball SD, Duren DL. Efficacy of an 8-Week Resistance Training Program in Older Adults: A Randomized Controlled Trial. J Aging Phys Act. 2021 Feb 1;29(1):121-129. doi: 10.1123/japa.2020-0078. Epub 2020 Aug 12.

Related Links

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Dana Duren
Organization
University of Missouri

Study Officials

  • Dana L Duren, PhD

    Director of Orthopaedic Research at the University of Missouri

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The primary investigator (Dr. Duren) will randomize participants into each of the three study groups. The research team responsible for assessments and analysis will be blinded to each participant's assignment. Dr. Duren will unblind the research team after the intervention period and data collection and analysis has been completed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into three groups of equal size. The experimental group (Stay Strong, Stay Healthy strength training program), the walking exercise group, and the sedentary control group will participate in the trial in parallel for up to ten weeks. After the intervention period, participants from each group will have the opportunity to participate in an interview about their experiences.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Director of Orthopaedic Research at the Missouri Orthopaedic Institute

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 19, 2019

Study Start

May 23, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 3, 2021

Results First Posted

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations