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Exercise for Adults With Limited Mobility

Primary Purpose

Mobility Limitation, Fall

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Group
Sponsored by
Youngstown State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Youngstown State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise Participants with Limited Mobility

Arm Description

The 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.

Outcomes

Primary Outcome Measures

Change in 6 Minute Walk Test
A submaximal exercise test used to assess aerobic capacity and cardiorespiratory fitness.

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2022
Last Updated
February 23, 2022
Sponsor
Youngstown State University
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1. Study Identification

Unique Protocol Identification Number
NCT05266573
Brief Title
Exercise for Adults With Limited Mobility
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2015 (Actual)
Primary Completion Date
March 10, 2017 (Actual)
Study Completion Date
March 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Youngstown State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Fall

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Participants with Limited Mobility
Arm Type
Experimental
Arm Description
The 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.
Intervention Type
Other
Intervention Name(s)
Exercise Group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in 6 Minute Walk Test
Description
A submaximal exercise test used to assess aerobic capacity and cardiorespiratory fitness.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in Activities Balance Confidence Scale
Description
Assesses balance confidence in ambulatory adults and can be used as a predictor for future falls in community dwelling older adults.
Time Frame
Baseline to 6 months
Title
Change in Short Form 36
Description
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.
Time Frame
Baseline to 6 months
Title
Change in Gait Speed
Description
A measure of the time it takes to travel 10 meters at a pace that is normal for the individual.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Eligibility Criteria
Inclusion Criteria: Limitations in mobility as evidenced by 6 Minute Walk Test score of < 499 meters Motivation to participate in an exercise program Exclusion Criteria: unable to follow commands unstable cardiac status greater than minimal assist for mobility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Landgraff, PhD
Organizational Affiliation
Youngstown State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17762378
Citation
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.
Results Reference
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PubMed Identifier
31592997
Citation
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.
Results Reference
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PubMed Identifier
19228241
Citation
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.
Results Reference
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PubMed Identifier
29505321
Citation
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.
Results Reference
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PubMed Identifier
30739500
Citation
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.
Results Reference
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PubMed Identifier
23676952
Citation
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.
Results Reference
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PubMed Identifier
29609662
Citation
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.
Results Reference
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PubMed Identifier
26445890
Citation
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.
Results Reference
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PubMed Identifier
26754477
Citation
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.
Results Reference
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PubMed Identifier
19940323
Citation
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.
Results Reference
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Exercise for Adults With Limited Mobility

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