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Clinical Trials/NCT03709251
NCT03709251
Terminated
Not Applicable

High Intensity Walking to Reduce Frailty

Northwestern University1 site in 1 country59 target enrollmentOctober 12, 2018
ConditionsFrailty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
Northwestern University
Enrollment
59
Locations
1
Primary Endpoint
Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to evaluate a physical therapist (PT) led gait training intervention for 100 older adults with pre-frailty or frailty. The goals of this study are To determine the effect of gait training intensity on frailty, mobility, physical functioning, and quality of life, as well as balance and healthcare utilization.

Detailed Description

Frailty is a leading cause of dependency among older adults, affects up to 60% of older adults, and is associated with an increased risk for falls, hospitalizations, institutionalization, and death. Exercise is the most widely recommended treatment for improving physical function among the frailty, but the optimal type or intensity of exercise is unknown. Walking is a preferred physical activity among older adults, however, there are no clear guidelines on the best intensity of walking to reduce frailty. The specific goal of this project is to compare a high intensity walking (HIW) intervention (70-80% of heart rate maximum) to a moderate intensity walking (MIW) intervention (50-60% of heart rate maximum) for pre-frail or frail older adults to determine the impact on frailty, mobility, balance, quality of life, and healthcare utilization.

Registry
clinicaltrials.gov
Start Date
October 12, 2018
End Date
March 2, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaret Danilovich

Assistant Professor

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Receiving services from CJE SeniorLife
  • Pre-frailty or frailty as determined on the SHARE-FI.
  • Able to ambulate at least 10 feet with moderate assistance (\<50% physical assistance) or less. Participants will be able to use their assistive device (e.g. cane or walker) during sessions.
  • \> 65 years of age
  • Provision of informed consent and clearance for participation as determined by the Exercise and Screening for You (EASY)

Exclusion Criteria

  • Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes)
  • Resting blood pressure \> 180/110 mmHg.59

Outcomes

Primary Outcomes

Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)

Time Frame: Baseline, Week 9, Month 6

Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity

Secondary Outcomes

  • Improved mobility as measured by 6 Minute Walk Test(Baseline, Week 9, Month 6)
  • Monthly self reports of Health Care Utilization(Baseline, Week 9, Month 3, Month 4, Month 5, Month 6)
  • Improved mobility as measured by Time Up and Go(Baseline, Week 9, Month 6)
  • Improved balance as measured by the Berg Balance Scale(Baseline, Week 9, Month 6)
  • Improved mobility as measured by gait speed(Baseline, Week 9, Month 6)
  • Patient Reported Outcomes Measure Information System (PROMIS) Global Health(Baseline, Week 9, Month 6)
  • Improved physical function on the Short Physical Performance Battery(Baseline, Week 9, Month 6)

Study Sites (1)

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