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OpenTrials
Completed

NCT Number: NCT02044783

Identifying and Treating Physical Function Impairment in Elders

Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.

Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.

Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.

Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.

Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)

Exclusion criteria

  • Inability to walk ≥30 feet without human assistance7
  • Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
  • Severe vision loss (legally blind)
  • Severe hearing loss
  • Medical condition that precludes increasing physical activity per primary care provider's assessment
  • Terminal diagnosis per primary care provider's assessment

Treatment and study plan

Behavioral Counseling

Behavioral

Primary outcomes

  1. Changes in physical activity as determined by accelerometer

    Time frame: 12 weeks

    Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.

  2. Changes in physical function as assessed by 400-meter walk speed

    Time frame: 12 weeks

    Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.

  3. Changes in physical function as assessed by Short Physical Performance Battery

    Time frame: 12 weeks

    Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention

  4. Change in physical function as assessed by lower extremity strength testing

    Time frame: 12 weeks

    Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .

Secondary outcomes

  1. Evaluation of standard implementation science process of reach

    Time frame: 1 year

    Reach is the percent of patients consented divided by the number eligible.

  2. Assessment of standard implementation science process metrics of acceptability

    Time frame: 1 year

    Acceptability will be assessed through structured surveys.

  3. Assessment of standard implementation science process metrics of implementation

    Time frame: 1 year

    Implementation process will be assessed by structured surveys

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2014
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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