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Mobility LimitationNCT05266573

Exercise for Adults With Limited Mobility

A study testing Exercise Group in people with Mobility Limitation and Fall, run by Youngstown State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness of a structured and progressive task-oriented, community based exercise program for older adults who have limitations in mobility and examine whether improvements in mobility and quality of life would be seen following completion at 6 months. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Mobility Limitation, Fall
What is being tested?
Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
8 Jan 2015to 10 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Limitations in mobility as evidenced by 6 Minute Walk Test score of < 499 meters
  • Motivation to participate in an exercise program

Who cannot join

  • unable to follow commands
  • unstable cardiac status
  • greater than minimal assist for mobility

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Youngstown State University

    Youngstown, Ohio, 44504

Other trials in United States

About this study

Official title: Effects of a Community Based, Task-Oriented Exercise Program on Community-Dwelling Older Adults With Limited Mobility: A 6-month Longitudinal Cohort Study

The purpose of this study is to evaluate the effectiveness of a structured and progressive task-oriented, community based exercise program for older adults who have limitations in mobility and examine whether improvements in mobility and quality of life would be seen following completion at 6 months.

Being tested
Exercise Group
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise GroupOther

    The exercise program is led by an individual who has a background in exercise physiology and is trained by the Physical Therapist. The task oriented exercise program consists of 45 to 60 minutes of group exercise sessions with the following components: warm-up period (dual task activity and walking progressively), stretching/strengthening/balance (gradual progression of activities and repetitions for 30 minutes), and obstacle course (6 to 15 minutes of obstacle course and challenged walking).

Study groups in NCT05266573
Study groupRoleWhat they receive
Exercise Participants with Limited MobilityExperimentalThe task oriented exercise program consists of 45 to 60 minutes of group exercise sessions with the following components: Warm Up: Walking which is progressively increased from 6 to 15 minutes. Dual task activity is introduced as tolerated by the participants. Participants are able to utilize assistive devices and there were additional supports provided. Stretching, Strengthening and Balance Activities: Gradual progression of activities and repetitions for 30 minutes that are tailored by the exercise instructor to each participant. Exercises are led by the trainer and performed at the balance bar, in a chair, or in standing. Task oriented activities included items such as: weight shifting, forward/backward/side stepping, squats, forward/backward/side leg raises, toe raises, seated trunk rotations, sit to stand, forward trunk bending, arm rotations, and marching. Walk/Obstacle Course: The final 6 to 15 minutes included "challenged walking" through an obstacle course.
Receives: Other: Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6 Minute Walk Test

    A submaximal exercise test used to assess aerobic capacity and cardiorespiratory fitness.

    Measured: Baseline to 6 months

Secondary outcomes (3)

  1. Change in Activities Balance Confidence Scale

    Assesses balance confidence in ambulatory adults and can be used as a predictor for future falls in community dwelling older adults.

    Measured: Baseline to 6 months

  2. Change in Short Form 36

    A 36-item survey measuring physical function (PF), role limitations due to physical health problems, role limitations due to emotional problems, bodily pain, general health perceptions, energy/fatigue, social functioning, as well as mental health and emotional well-being.

    Measured: Baseline to 6 months

  3. Change in Gait Speed

    A measure of the time it takes to travel 10 meters at a pace that is normal for the individual.

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start8 Jan 2015
  3. Primary completion10 Mar 2017
  4. Study completion10 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266573
Sponsor's protocol ID
109-2013
Status last verified
Feb 2022
First submitted
14 Feb 2022
Last updated
4 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.

    PubMed 17762378

  • Alqahtani BA, Sparto PJ, Whitney SL, Greenspan SL, Perera S, VanSwearingen J, Brach JS. Effect of Community-Based Group Exercise Interventions on Standing Balance and Strength in Independent Living Older Adults. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):E7-E15. doi: 10.1519/JPT.0000000000000221.

    PubMed 31592997

  • Rensink M, Schuurmans M, Lindeman E, Hafsteinsdottir T. Task-oriented training in rehabilitation after stroke: systematic review. J Adv Nurs. 2009 Apr;65(4):737-54. doi: 10.1111/j.1365-2648.2008.04925.x. Epub 2009 Feb 9.

    PubMed 19228241

  • Tisher K, Mann K, VanDyke S, Johansson C, Vallabhajosula S. Functional measures show improvements after a home exercise program following supervised balance training in older adults with elevated fall risk. Physiother Theory Pract. 2019 Apr;35(4):305-317. doi: 10.1080/09593985.2018.1444116. Epub 2018 Mar 5.

    PubMed 29505321

  • Skrastins O, Tsotsos S, Aqeel H, Qiang A, Renton J, Howe JA, Tee A, Moller J, Salbach NM. Fitness coordinators' and fitness instructors' perspectives on implementing a task-oriented community exercise program within a healthcare-recreation partnership for people with balance and mobility limitations: a qualitative study. Disabil Rehabil. 2020 Sep;42(19):2687-2695. doi: 10.1080/09638288.2019.1570357. Epub 2019 Feb 10.

    PubMed 30739500

  • Salbach NM, Howe JA, Brunton K, Salisbury K, Bodiam L. Partnering to increase access to community exercise programs for people with stroke, acquired brain injury, and multiple sclerosis. J Phys Act Health. 2014 May;11(4):838-45. doi: 10.1123/jpah.2012-0183. Epub 2013 May 13.

    PubMed 23676952

  • Salbach NM, Howe JA, Baldry D, Merali S, Munce SEP. Considerations for expanding community exercise programs incorporating a healthcare-recreation partnership for people with balance and mobility limitations: a mixed methods evaluation. BMC Res Notes. 2018 Apr 2;11(1):214. doi: 10.1186/s13104-018-3313-x.

    PubMed 29609662

  • Merali S, Cameron JI, Barclay R, Salbach NM. Characterising community exercise programmes delivered by fitness instructors for people with neurological conditions: a scoping review. Health Soc Care Community. 2016 Nov;24(6):e101-e116. doi: 10.1111/hsc.12282. Epub 2015 Oct 7.

    PubMed 26445890

  • Chompoonimit A, Nualnetr N. The impact of task-oriented client-centered training on individuals with spinal cord injury in the community. Spinal Cord. 2016 Oct;54(10):849-854. doi: 10.1038/sc.2015.237. Epub 2016 Jan 12.

    PubMed 26754477

  • Bird ML, Hill K, Ball M, Williams AD. Effects of resistance- and flexibility-exercise interventions on balance and related measures in older adults. J Aging Phys Act. 2009 Oct;17(4):444-54. doi: 10.1123/japa.17.4.444.

    PubMed 19940323

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Group in people with Mobility Limitation and Fall, run by Youngstown State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6 Minute Walk Test (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266573, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.

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