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

Primary Purpose

Gait, Unsteady

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength training
Endurance training
Flexibility training
Task Specific timing and coordination training
Physical activity behavioral intervention
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait, Unsteady

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Standard-plus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gait speed
Usual walking speed over a short distance. A physiologic measure recorded in m/s.

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2016
Last Updated
September 17, 2021
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02663778
Brief Title
Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults: Program to Improve Mobility in Aging
Acronym
PRIMA
Official Title
Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard-plus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Description
weight lifting to increase muscle strength
Intervention Type
Behavioral
Intervention Name(s)
Endurance training
Intervention Description
treadmill walking to increase endurance
Intervention Type
Behavioral
Intervention Name(s)
Flexibility training
Intervention Description
stretches to improve flexibility
Intervention Type
Behavioral
Intervention Name(s)
Task Specific timing and coordination training
Intervention Description
stepping and walking patterns to improve timing and coordination of gait
Intervention Type
Behavioral
Intervention Name(s)
Physical activity behavioral intervention
Intervention Description
Intervention to encourage participants to be more physically active
Primary Outcome Measure Information:
Title
Gait speed
Description
Usual walking speed over a short distance. A physiologic measure recorded in m/s.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Smoothness of walking
Description
acceleration signal of usual walking. physiologic measure of the acceleration of walking.
Time Frame
12, 24, and 36 weeks
Title
gait variability
Description
fluctuations in gait characteristics from step to step. physiologic measure of the spatial and temporal gait characteristics
Time Frame
12, 24, 36 weeks
Title
Late Life Function and Disability Instrument - function subscale
Description
Self report measure of function
Time Frame
12, 24, and 36 weeks
Title
Late Life Function and Disability Instrument - disability subscale
Description
Self report measure of disability
Time Frame
12, 24, and 36 weeks
Title
Lower extremity strength
Description
physiologic measure of leg strength
Time Frame
12, 24, and 36 weeks
Title
Lower extremity muscle power
Description
physiologic measure of leg muscle power
Time Frame
12, 24, and 36 weeks
Title
Six minute walk test
Description
physiologic measure of walking endurance
Time Frame
12, 24, and 36 weeks
Title
Chair sit and reach test
Description
physiologic measure of flexibility
Time Frame
12, 24, and 36 weeks
Title
Physical activity
Description
Physiologic measure of physical activity measured using an accelerometer.
Time Frame
12, 24, and 36 weeks
Other Pre-specified Outcome Measures:
Title
Falls
Description
Self reported falls collected monthly by telephone
Time Frame
16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Title
Emergency room visits
Description
Self reported emergency room visits collected monthly by telephone
Time Frame
16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks
Title
Hospital admission
Description
Self reported hospital admission collected monthly by telephone
Time Frame
16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 65 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer S Brach, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35604689
Citation
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.
Results Reference
derived

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

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