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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02663778
Acronym
PRIMA
Enrollment
353
Registered
2016-01-26
Start date
2016-04-30
Completion date
2021-02-28
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Unsteady

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.

Interventions

BEHAVIORALStrength training

weight lifting to increase muscle strength

BEHAVIORALEndurance training

treadmill walking to increase endurance

stretches to improve flexibility

stepping and walking patterns to improve timing and coordination of gait

Intervention to encourage participants to be more physically active

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Gait speed12 weeksUsual walking speed over a short distance. A physiologic measure recorded in m/s.

Secondary

MeasureTime frameDescription
gait variability12, 24, 36 weeksfluctuations in gait characteristics from step to step. physiologic measure of the spatial and temporal gait characteristics
Late Life Function and Disability Instrument - function subscale12, 24, and 36 weeksSelf report measure of function
Late Life Function and Disability Instrument - disability subscale12, 24, and 36 weeksSelf report measure of disability
Lower extremity strength12, 24, and 36 weeksphysiologic measure of leg strength
Lower extremity muscle power12, 24, and 36 weeksphysiologic measure of leg muscle power
Smoothness of walking12, 24, and 36 weeksacceleration signal of usual walking. physiologic measure of the acceleration of walking.
Chair sit and reach test12, 24, and 36 weeksphysiologic measure of flexibility
Physical activity12, 24, and 36 weeksPhysiologic measure of physical activity measured using an accelerometer.
Six minute walk test12, 24, and 36 weeksphysiologic measure of walking endurance

Other

MeasureTime frameDescription
Emergency room visits16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeksSelf reported emergency room visits collected monthly by telephone
Hospital admission16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeksSelf reported hospital admission collected monthly by telephone
Falls16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and 60 weeksSelf reported falls collected monthly by telephone

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026