NCT01076413

Brief Summary

The purpose of this research study is to compare two different exercise treatments for walking problems in older adults. The investigators want to determine if participation in the exercise programs for 3 months will improve walking abilities by improving balance and strength.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration 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

February 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

February 24, 2010

Last Update Submit

January 21, 2016

Conditions

Gait

Keywords

gaitexerciseskill-basedaerobic

Outcome Measures

Primary Outcomes (3)

  • Gait

    gait characteristics, smoothness of walking, 6 MWT, complex walking tests, GARS-M, SPPB, energy cost, SAFFE, GES, figure of 8

    12 weeks

  • Physical function

    LLFDI function and disability scales

    12 weeks

  • Physical Activity

    Actigraph accelerometer

    12 weeks

Secondary Outcomes (1)

  • Disability and health care costs

    6 months post exercise

Study Arms (2)

skill-based exercise

EXPERIMENTAL

2 times per week for 12 weeks. warm-up, stretching, strengthening, and skill-based exercises. Pre-gait and gait activities including stepping patterns and walking patterns and treadmill training at various walking speeds

Behavioral: skill based exercise

aerobic exercise training

ACTIVE COMPARATOR

warm-up, strengthening and aerobic conditioning (treadmill walking)

Behavioral: aerobic conditioning

Interventions

skill based exerciseBEHAVIORAL

2 times per week for 12 weeks Pre gait and gait activities

skill-based exercise
aerobic conditioningBEHAVIORAL

2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking

aerobic exercise training

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 ≥1.0 m/s
  • Completes a figure-of-eight walk in \> 8.0 seconds

You may not qualify if:

  • Inability to participate in testing:
  • persistent lower extremity pain that is present on most days of the week and crepitus, tenderness or enlargement of joints of the lower extremity (arthritis).84
  • 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 (lumbar stenosis)
  • calf pain or cramping which worsens with walking and is relieved by rest (PAD)
  • refusal to walk on a treadmill
  • Safety concerns:
  • 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 minute85
  • diagnosed dementia or cognitive impairment defined as a MMSE score \< 24
  • hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
  • severe visual impairment with visual acuity \< 20/70 with best correction
  • history of stroke
  • fixed or fused lower extremity joints such as hip, knee or ankle
  • lower extremity strength \<4/5 on manual muscle testing
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (2)

  • Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016/j.apmr.2014.10.018. Epub 2014 Nov 10.

    PMID: 25448244RESULT

  • Brach JS, Van Swearingen JM, Perera S, Wert DM, Studenski S. Motor learning versus standard walking exercise in older adults with subclinical gait dysfunction: a randomized clinical trial. J Am Geriatr Soc. 2013 Nov;61(11):1879-86. doi: 10.1111/jgs.12506. Epub 2013 Oct 28.

    PMID: 24219189RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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
Associate Professor

Study Record Dates

First Submitted

February 24, 2010

First Posted

February 26, 2010

Study Start

March 1, 2010

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

US(1)