Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults: Program to Improve Mobility in Aging
PRIMA
1 other identifier
interventional
353
1 country
1
Brief Summary
This randomized clinical trial targets 248 community-dwelling older adults with impaired mobility (i.e. walking slowly; gait speed \< 1.20 m/s). The trial compares a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training to a standard 12 week strength, endurance and flexibility program. The primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent components of the intervention and measures of activity and participation. Delayed and sustained effects of the intervention are examined at 24 and 36 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedSeptember 20, 2021
September 1, 2021
3.8 years
January 21, 2016
September 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Gait speed
Usual walking speed over a short distance. A physiologic measure recorded in m/s.
12 weeks
Secondary Outcomes (9)
Smoothness of walking
12, 24, and 36 weeks
gait variability
12, 24, 36 weeks
Late Life Function and Disability Instrument - function subscale
12, 24, and 36 weeks
Late Life Function and Disability Instrument - disability subscale
12, 24, and 36 weeks
Lower extremity strength
12, 24, and 36 weeks
- +4 more secondary outcomes
Other Outcomes (3)
Falls
16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Emergency room visits
16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Hospital admission
16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Study Arms (2)
Standard
ACTIVE COMPARATORThe standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.
Standard-plus
EXPERIMENTALThe standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.
Interventions
stepping and walking patterns to improve timing and coordination of gait
Intervention to encourage participants to be more physically active
Eligibility Criteria
You may qualify if:
- years of age and older
- Ambulatory without an assistive device or the assistance of another person
- Usual 4 meter gait speed \> 0.60 m/s and \< 1.2 m/s
- Physician clearance to participate in a moderate intensity exercise program
- Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.7
You may not qualify if:
- persistent lower extremity pain that is present on most days of the week
- back pain that is present on most days of the weeks and interferes with walking and activities of daily living or back pain that increases with walking
- refuse to walk on a treadmill
- plans to move out of the area in the next 5 years
- dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
- any acute illness or medical condition that is not stable according to the approving physician
- resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate \> 100 or \< 40 beats per minute
- diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination \<79
- hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
- severe visual impairment
- fixed or fused lower extremity joints such as hip, knee or ankle
- lower extremity strength \<3/5 on manual muscle testing
- lower extremity amputation
- progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219, United States
Related Publications (2)
Dunlap PM, Crane BM, Perera S, Moored KD, Carlson MC, Brach JS, Klatt BN, Rosso AL. Effects of a Physical Therapist Intervention on GPS Indicators of Community Mobility in Older Adults: A Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2023 Aug 1;103(8):pzad071. doi: 10.1093/ptj/pzad071.
PMID: 37364044DERIVEDBrach JS, Perera S, Shuman V, Gil AB, Kriska A, Nadkarni NK, Rockette-Wagner B, Cham R, VanSwearingen JM. Effect of Timing and Coordination Training on Mobility and Physical Activity Among Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212921. doi: 10.1001/jamanetworkopen.2022.12921.
PMID: 35604689DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer S Brach, PhD, PT
University of Pittsburgh
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
- PhD
Study Record Dates
First Submitted
January 21, 2016
First Posted
January 26, 2016
Study Start
April 1, 2016
Primary Completion
January 1, 2020
Study Completion
February 1, 2021
Last Updated
September 20, 2021
Record last verified: 2021-09