NCT02663778

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

January 21, 2016

Last Update Submit

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 COMPARATOR

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 trainingBehavioral: Endurance trainingBehavioral: Flexibility trainingBehavioral: Physical activity behavioral intervention

Standard-plus

EXPERIMENTAL

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 trainingBehavioral: Endurance trainingBehavioral: Flexibility trainingBehavioral: Task Specific timing and coordination trainingBehavioral: Physical activity behavioral intervention

Interventions

weight lifting to increase muscle strength

StandardStandard-plus

treadmill walking to increase endurance

StandardStandard-plus

stretches to improve flexibility

StandardStandard-plus

stepping and walking patterns to improve timing and coordination of gait

Standard-plus

Intervention to encourage participants to be more physically active

StandardStandard-plus

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Gait Disorders, Neurologic

Interventions

Resistance TrainingEndurance Training

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jennifer S Brach, PhD, PT

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

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

Locations