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

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT02663778
Collaborator
(none)
353
1
2
58.1
6.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Strength training
  • Behavioral: Endurance training
  • Behavioral: Flexibility training
  • Behavioral: Task Specific timing and coordination training
  • Behavioral: Physical activity behavioral intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
353 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

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: Task Specific timing and coordination training
stepping and walking patterns to improve timing and coordination of gait

Behavioral: Physical activity behavioral intervention
Intervention to encourage participants to be more physically active

Outcome Measures

Primary Outcome Measures

  1. Gait speed [12 weeks]

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

Secondary Outcome Measures

  1. Smoothness of walking [12, 24, and 36 weeks]

    acceleration signal of usual walking. physiologic measure of the acceleration of walking.

  2. gait variability [12, 24, 36 weeks]

    fluctuations in gait characteristics from step to step. physiologic measure of the spatial and temporal gait characteristics

  3. Late Life Function and Disability Instrument - function subscale [12, 24, and 36 weeks]

    Self report measure of function

  4. Late Life Function and Disability Instrument - disability subscale [12, 24, and 36 weeks]

    Self report measure of disability

  5. Lower extremity strength [12, 24, and 36 weeks]

    physiologic measure of leg strength

  6. Lower extremity muscle power [12, 24, and 36 weeks]

    physiologic measure of leg muscle power

  7. Six minute walk test [12, 24, and 36 weeks]

    physiologic measure of walking endurance

  8. Chair sit and reach test [12, 24, and 36 weeks]

    physiologic measure of flexibility

  9. Physical activity [12, 24, and 36 weeks]

    Physiologic measure of physical activity measured using an accelerometer.

Other Outcome Measures

  1. Falls [16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks]

    Self reported falls collected monthly by telephone

  2. Emergency room visits [16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks]

    Self reported emergency room visits collected monthly by telephone

  3. Hospital admission [16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeks]

    Self reported hospital admission collected monthly by telephone

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15219

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jennifer S. Brach, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02663778
Other Study ID Numbers:
  • PRO14080080
First Posted:
Jan 26, 2016
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021