Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults: Program to Improve Mobility in Aging (PRIMA)

Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Gait, Unsteady
• Intervention / Treatment: Behavioral: Strength training; Behavioral: Endurance training; Behavioral: Flexibility training; Behavioral: Physical activity behavioral intervention; Behavioral: Task Specific timing and coordination training

Detailed Description

Walking difficulty is common and costly in older adults. While traditional exercise has been shown to promote physical and mental health and may prevent walking difficulty, such exercise has focused on strength and endurance, and has overlooked a critical component of walking ability; the timing and coordination of movement. Aging and disease alter timing and coordination as reflected by slowed neuromotor performance, increased gait variability and reduced smoothness of movement. Task specific timing and coordination exercise that includes practice of smooth coordinated aspects of gait over multiple walking conditions has the potential to improve walking ability greater than a standard program. Our preliminary data suggest that interventions on timing and coordination of gait impact mobility greater than the standard strength and endurance program. The next key step and the objective of this proposal is to combine the two interventions to determine if potential gains in mobility, activity and participation obtained from a standard plus timing and coordination program, are larger than the gains obtained from the standard program alone. Therefore, the primary aim of the proposed project is to evaluate the impact of adding timing and coordination training to standard strength and endurance training on mobility. Secondary aims include examining 1) additional outcomes representing the components of the intervention and measures of activity and participation, 2) the delayed and sustained effects of the intervention, and 3) the effects of the intervention within various other subgroups of interest. This randomized clinical trial in 248 community-dwelling older adults who walk slowly (i.e. < 1.20 m/s) will compare a standard 12 week strength, endurance and flexibility program to a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training. The primary outcome is gait speed at 12 weeks. We will also examine secondary and tertiary outcomes representing components of the intervention and measures of activity and participation and the delayed and sustained effects at 24 and 36 weeks. The findings from this efficacy trial will provide evidence for the added value of task specific timing and coordination training for promoting walking ability in older adults and will form the basis for future effectiveness trials. Future work includes translation to nonprofessional exercise leaders with the long-term goal to incorporate neurological training into standard exercise programs for health promotion for older adults.

• Study Type: Interventional
• Enrollment (Actual): 353
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 65 years of age and older
2. Ambulatory without an assistive device or the assistance of another person
3. Usual 4 meter gait speed > 0.60 m/s and < 1.2 m/s
4. Physician clearance to participate in a moderate intensity exercise program
5. Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.7

Exclusion Criteria:

1. persistent lower extremity pain that is present on most days of the week
2. 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
3. refuse to walk on a treadmill
4. plans to move out of the area in the next 5 years
5. dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
6. any acute illness or medical condition that is not stable according to the approving physician
7. resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute
8. diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination <79
9. hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
10. severe visual impairment
11. fixed or fused lower extremity joints such as hip, knee or ankle
12. lower extremity strength <3/5 on manual muscle testing
13. lower extremity amputation
14. progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.	Behavioral: Strength training; weight lifting to increase muscle strength; Behavioral: Endurance training; treadmill walking to increase endurance; Behavioral: Flexibility training; stretches to improve flexibility; Behavioral: Physical activity behavioral intervention; Intervention to encourage participants to be more physically active
Experimental: Standard-plus; The 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.	Behavioral: Strength training; weight lifting to increase muscle strength; Behavioral: Endurance training; treadmill walking to increase endurance; Behavioral: Flexibility training; stretches to improve flexibility; Behavioral: Physical activity behavioral intervention; Intervention to encourage participants to be more physically active; Behavioral: Task Specific timing and coordination training; stepping and walking patterns to improve timing and coordination of gait

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	Usual walking speed over a short distance. A physiologic measure recorded in m/s.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoothness of walking	acceleration signal of usual walking. physiologic measure of the acceleration of walking.	12, 24, and 36 weeks
gait variability	fluctuations in gait characteristics from step to step. physiologic measure of the spatial and temporal gait characteristics	12, 24, 36 weeks
Late Life Function and Disability Instrument - function subscale	Self report measure of function	12, 24, and 36 weeks
Late Life Function and Disability Instrument - disability subscale	Self report measure of disability	12, 24, and 36 weeks
Lower extremity strength	physiologic measure of leg strength	12, 24, and 36 weeks
Lower extremity muscle power	physiologic measure of leg muscle power	12, 24, and 36 weeks
Six minute walk test	physiologic measure of walking endurance	12, 24, and 36 weeks
Chair sit and reach test	physiologic measure of flexibility	12, 24, and 36 weeks
Physical activity	Physiologic measure of physical activity measured using an accelerometer.	12, 24, and 36 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Self reported falls collected monthly by telephone	16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Emergency room visits	Self reported emergency room visits collected monthly by telephone	16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Hospital admission	Self reported hospital admission collected monthly by telephone	16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jennifer S Brach, PhD, PT, University of Pittsburgh

Publications and helpful links

General Publications

• Brach 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Gait Disorders, Neurologic
• Other Study ID Numbers: PRO14080080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided