We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01986647
First Posted: November 18, 2013
Last Update Posted: October 12, 2017
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.
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose

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 Intervention
Physical Disability Behavioral: On the Move group exercise Behavioral: Standard group exercise

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Self-reported function and disability and walking ability [ Time Frame: 12 weeks ]
    Self-reported function and disability as measured by the Late Life Function and Disability Index (LLFDI)and walking ability as measured by the Six Minute Walk test and gait speed


Secondary Outcome Measures:
  • Satisfaction [ Time Frame: 12 weeks ]
    Participant satisfaction will be measured by satisfaction surveys and personal interviews.


Other Outcome Measures:
  • attendance rates [ Time Frame: 12 weeks ]
    The number of exercise classes attended by the subjects.

  • Risks to subjects [ Time Frame: throughout 12 week program ]
    Adverse events such as falls, soft tissue injuries, and muscle soreness will be used as a measure of risk

  • Measures of Mobility [ Time Frame: 12 weeks ]
    gait efficacy scale, figure of 8 walk test, challenging gait tasks, and gait variability will be used as measures of mobility.

  • Falls [ Time Frame: 1 year ]
    Self-report of falls will be assessed starting at the completion of the exercise class, once a month for 12 months using interactive voice recognition phone calls.


Estimated Enrollment: 400
Study Start Date: December 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: On the Move Exercise group
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.
Behavioral: On the Move group exercise
Active Comparator: Standard group exercise program
Standard impairment based seated group exercise program. 2 times per week for 12 weeks, approximately 1 hour class.
Behavioral: Standard group exercise
Experimental: Exercise leader
Exercise class will be led by a person who is trained in exercise such as exercise physiologist, physical therapist, physical therapist assistant
Behavioral: On the Move group exercise
Experimental: Activity Personnel
Exercise class will be led by a member of the facility who does not necessarily have formal exercise training. this person will be trained by the research staff to lead the class.
Behavioral: Standard group exercise

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Jennifer S Brach, PhD University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01986647     History of Changes
Other Study ID Numbers: PRO13090264
First Submitted: November 11, 2013
First Posted: November 18, 2013
Last Update Posted: October 12, 2017
Last Verified: March 2016

Keywords provided by University of Pittsburgh:
exercise
older adults
mobility disability