Identifying and Treating Physical Function Impairment in Elders

NCT02044783 | Completed

• 1 other identifier: 13-3021
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Activity; Physical Impairment

Keywords

Adults; Elderly

Outcome Measures

Primary Outcomes (4)

• Changes in physical activity as determined by accelerometer

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

  12 weeks

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

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

  12 weeks

• Changes in physical function as assessed by Short Physical Performance Battery

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

  12 weeks

• Change in physical function as assessed by lower extremity strength testing

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

  12 weeks

Secondary Outcomes (3)

• Evaluation of standard implementation science process of reach

  1 year

• Assessment of standard implementation science process metrics of acceptability

  1 year

• Assessment of standard implementation science process metrics of implementation

  1 year

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers

Behavioral: Behavioral Counseling

Usual Care

NO INTERVENTION

Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic). No behavioral counseling.

Interventions

Behavioral Counseling BEHAVIORAL

Behavioral Intervention

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amy Huebschmann, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

US (1)