NCT01986647

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration 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

First Submitted

Initial submission to the registry

November 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 22, 2019

Completed
Last Updated

March 22, 2019

Status Verified

December 1, 2018

Enrollment Period

2.4 years

First QC Date

November 11, 2013

Results QC Date

August 29, 2017

Last Update Submit

December 14, 2018

Conditions

Physical Disability

Keywords

exerciseolder adultsmobility disability

Outcome Measures

Primary Outcomes (4)

  • Change in Self-reported Overall Function From Baseline to 12 Weeks

    Late Life Function and Disability Index (LLFDI) overall function. Scores range from 0-100 with higher score representing better function.

    baseline and 12 weeks

  • Change in Self-reported Disability From Baseline to 12 Weeks

    Late Life Function and Disability Instrument (LLFDI) disability frequency component. Scores range from 0-100 with higher scores representing better (less) disability.

    12 weeks

  • Change in Gait Speed From Baseline to 12 Weeks

    Gait speed in m/s

    12 weeks

  • Change in Six Minute Walk Distance From Baseline to 12 Weeks

    distance walked in 6 minutes

    12 weeks

Secondary Outcomes (11)

  • Number of Participants Who Reported They Benefited a Good Bit or Somewhat From the Class

    12 weeks

  • Number of Participants Who Reported That the Class Was at Least Somewhat Challenging

    12 weeks

  • Number of Participants Reporting That They Received a Just Right Amount of Individualized Instruction

    12 weeks

  • Number of Participants Who Reported That They Felt Safe or Very Safe During the Exercise.

    12 weeks

  • Number of Participants Who Reported They Were Satisfied or Very Satisfied With the Program.

    12 weeks

  • +6 more secondary outcomes

Other Outcomes (1)

  • Attendance Rates

    12 weeks

Study Arms (4)

On the Move Exercise - exercise leader

EXPERIMENTAL

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

Standard program - exercise leader

ACTIVE COMPARATOR

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

On the Move - staff activity personnel

ACTIVE COMPARATOR

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

Standard - staff activity personnel

ACTIVE COMPARATOR

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

Interventions

On the Move exercise - exercise leaderBEHAVIORAL

exercise physiologists

On the Move Exercise - exercise leader
Standard program - exercise leaderBEHAVIORAL

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

Standard program - exercise leader
On the Move exercise - staff activity personnelBEHAVIORAL

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.

On the Move - staff activity personnel
Standard program - staff activity personnelBEHAVIORAL

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.

Standard - staff activity personnel

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (3)

  • Brach JS, Perera S, Gilmore S, VanSwearingen JM, Brodine D, Wert D, Nadkarni NK, Ricci E. Stakeholder involvement in the design of a patient-centered comparative effectiveness trial of the "On the Move" group exercise program in community-dwelling older adults. Contemp Clin Trials. 2016 Sep;50:135-42. doi: 10.1016/j.cct.2016.08.003. Epub 2016 Aug 10.

    PMID: 27521806BACKGROUND

  • Coyle PC, Perera S, Albert SM, Freburger JK, VanSwearingen JM, Brach JS. Potential long-term impact of "On The Move" group-exercise program on falls and healthcare utilization in older adults: an exploratory analysis of a randomized controlled trial. BMC Geriatr. 2020 Mar 16;20(1):105. doi: 10.1186/s12877-020-1506-3.

    PMID: 32178633DERIVED

  • Brach JS, Perera S, Gilmore S, VanSwearingen JM, Brodine D, Nadkarni NK, Ricci E. Effectiveness of a Timing and Coordination Group Exercise Program to Improve Mobility in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2017 Oct 1;177(10):1437-1444. doi: 10.1001/jamainternmed.2017.3609.

    PMID: 28806436DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Jennifer S. Brach, PhD, PT
Organization
University of Pittsburgh
jbrach@pitt.edu
412-383-6533

Study Officials

  • Jennifer S Brach, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 18, 2013

Study Start

December 1, 2013

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

March 22, 2019

Results First Posted

March 22, 2019

Record last verified: 2018-12

Locations

US(1)