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On the Move: Optimizing Participation in Group Exercise (OTM-PCORI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986647
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jennifer S. Brach, University of Pittsburgh

Brief Summary:

Community-dwelling older adults fear loss of independence and nursing home placement more than death. Walking difficulty often leads to loss of independence. Exercise is beneficial to physical and mental health and may prevent walking difficulty and promote independence. Recognizing the importance of exercise, senior housing facilities offer exercise programs to their residents. The exercise programs are often group-based, seated range of motion exercises that do not challenge the older adult; consequently participation rates and resident satisfaction are low.

If the goal is to improve walking to promote independence than the exercise program should specifically target walking. Therefore, we developed a challenging, group exercise program entitled "On the Move" which focuses on the fundamentals of walking. In this research study we will determine if the On the Move program is better than a standard program at improving walking and promoting independence and if the same benefits can be obtained if the On the Move program is delivered by staff of the senior living facilities instead of an exercise leader. To answer these questions, 400 community-dwelling older adults living in 32 different Independent Living Facilities and Senior High Rises or living in the community and attending senior community centers will be randomly assigned to either the 12 week On the Move group exercise program or the standard group exercise program delivered by either an exercise leader or staff activity personnel. Participants' walking and reported ability to carry out everyday activities (functional ability) will be assessed before and after the 12 week program. We will also assess participant safety and satisfaction with the exercise program and instructor.

The findings from this research study will provide evidence for the value of the On the Move group exercise program and will better inform patient choices regarding participation in exercise programs. If successful in improving walking and promoting independence and acceptable to the older adult, the On the Move program could be incorporated into exercise programming for older adults in community centers, health clubs, and senior residences across the country.


Condition or disease Intervention/treatment Phase
Physical Disability Behavioral: On the Move exercise - exercise leader Behavioral: Standard program - exercise leader Behavioral: On the Move exercise - staff activity personnel Behavioral: Standard program - staff activity personnel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: On the Move: Optimizing Participation in Group Exercise to Prevent Walking Difficulty in At-Risk Older Adults
Study Start Date : December 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: On the Move Exercise - exercise leader
On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Led by exercise leader
Behavioral: On the Move exercise - exercise leader
exercise physiologists

Active Comparator: Standard program - exercise leader
Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Led by exercise leader
Behavioral: Standard program - exercise leader
This is an impairment-based exercise program focusing on flexibility, strength and endurance and is taught by research staff who are PTs, PTAs, or exercise physiologists

Active Comparator: On the Move - staff activity personnel
On the Move group exercise - 2 times per week for 12 weeks. Each session lasts approximately 1 hour. Timing and coordination exercises to improve walking. Led by activity personnel.
Behavioral: On the Move exercise - staff activity personnel
this is a group exercise program focusing on the timing and coordination of walking. The program is taught by a person from the facility that the research team trained.

Active Comparator: Standard - staff activity personnel
Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class. Led by staff activity personnel
Behavioral: Standard program - staff activity personnel
This is an impairment-based exercise program focusing on flexibility, strength and endurance and is taught by a member of the facility that the research staff trained.




Primary Outcome Measures :
  1. Change in Self-reported Overall Function From Baseline to 12 Weeks [ Time Frame: baseline and 12 weeks ]
    Late Life Function and Disability Index (LLFDI) overall function. Scores range from 0-100 with higher score representing better function.

  2. Change in Self-reported Disability From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    Late Life Function and Disability Instrument (LLFDI) disability frequency component. Scores range from 0-100 with higher scores representing better (less) disability.

  3. Change in Gait Speed From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    Gait speed in m/s

  4. Change in Six Minute Walk Distance From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    distance walked in 6 minutes


Secondary Outcome Measures :
  1. Number of Participants Who Reported They Benefited a Good Bit or Somewhat From the Class [ Time Frame: 12 weeks ]
    Participant satisfaction will be measured by satisfaction surveys and personal interviews. Benefited from class a good bit or somewhat

  2. Number of Participants Who Reported That the Class Was at Least Somewhat Challenging [ Time Frame: 12 weeks ]
    Measured by question on the satisfaction questionnaire. Question asked participants to rate how challenging the class was.

  3. Number of Participants Reporting That They Received a Just Right Amount of Individualized Instruction [ Time Frame: 12 weeks ]
    Question from satisfaction questionnaire - that asked participants their opinion on the amount of individualized instruction they received.

  4. Number of Participants Who Reported That They Felt Safe or Very Safe During the Exercise. [ Time Frame: 12 weeks ]
    Question from the satisfaction questionnaire.

  5. Number of Participants Who Reported They Were Satisfied or Very Satisfied With the Program. [ Time Frame: 12 weeks ]
    Question from the satisfaction questionnaire.

  6. Number of Participants Who Reported They Would Definitely or Probably Continue With the Program [ Time Frame: 12 weeks ]
    Question from the satisfaction questionnaire.

  7. Change in Figure 8 Walk Test From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    Time it takes to walk a figure 8 around 2 cones 5 feet apart. Greater time in seconds represents poorer performance

  8. Change in Modified Gait Efficacy Scale From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    Confidence in walking was measured by the modified gait efficacy scale (mGES). Scores range from 0-100 with higher scores indicating greater confidence.

  9. Change in Short Physical Performance Battery From Baseline to 12weeks [ Time Frame: 12 week ]
    Short physical Performance Battery is a performance test that includes gait speed, 5 time sit to stand and standing balance. Scores range from 0-12 with greater scores indicating better performance.

  10. Change in Stance Time Variability From Baseline to 12weeks [ Time Frame: 12 week ]
    variability of individual stance times during walking as measured from a electronic walkway. Measured as the standard deviation of all stance times. greater values represent greater variability which is related to poorer outcomes.

  11. Change in Narrow Walk Time From Baseline to 12 Weeks [ Time Frame: 12 weeks ]
    Time to walk narrow pathway. Greater values (times) indicate poorer performance.


Other Outcome Measures:
  1. Attendance Rates [ Time Frame: 12 weeks ]
    The number of participants attending 20 or more exercise classes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65 years of age or older
  • resident of University of Pittsburgh Medical Center Independent Living Facility or senior housing site
  • Ambulate independently for household distance (may use a straight cane)

Exclusion Criteria:

  • non English speaking
  • impaired cognition defined as unable to follow 2 step commands
  • plans to leave area in next 4 months
  • progressive neuromuscular disorder
  • any acute illness or medical condition that is not stable
  • inappropriate response on 6 minute walk test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986647


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jennifer S Brach, PhD University of Pittsburgh

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer S. Brach, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01986647    
Other Study ID Numbers: PRO13090264
First Posted: November 18, 2013    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Keywords provided by Jennifer S. Brach, University of Pittsburgh:
exercise
older adults
mobility disability