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High Intensity Walking to Reduce Frailty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03709251
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
Margaret Danilovich, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Frailty Behavioral: High Intensity Walking Behavioral: Casual Speed Walking Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Intensity Walking to Reduce Frailty
Actual Study Start Date : October 12, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: High Intensity Walking
HIW (70-80% Heart Rate max)
Behavioral: High Intensity Walking
Intense walking activity at an intensity of 70-80% of the maximum heart rate

Experimental: Casual Speed Walking
Self selected pace
Behavioral: Casual Speed Walking
Moderate intensity (50-60% of Heart Rate maximum)

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Improved mobility as measured by gait speed [ Time Frame: Baseline, Week 9, Month 6 ]
    Measures related to overall health and mobility

  2. Improved mobility as measured by 6 Minute Walk Test [ Time Frame: Baseline, Week 9, Month 6 ]
    Measures related to mobility

  3. Improved mobility as measured by Time Up and Go [ Time Frame: Baseline, Week 9, Month 6 ]
    Measures related to mobility

  4. Improved physical function on the Short Physical Performance Battery [ Time Frame: Baseline, Week 9, Month 6 ]
    Provide an overall assessment of functional status and physical performance

  5. Improved balance as measured by the Berg Balance Scale [ Time Frame: Baseline, Week 9, Month 6 ]
    The Berg Balance Scale is a valid and reliable 14 item tool to evaluate static and dynamic balance among older adults. Minimum Score 0 to Maximum Score 56. • Score of < 45 indicates individuals may be at greater risk of falling

  6. Monthly self reports of Health Care Utilization [ Time Frame: Baseline, Week 9, Month 3, Month 4, Month 5, Month 6 ]
    Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits

  7. Patient Reported Outcomes Measure Information System (PROMIS) Global Health [ Time Frame: Baseline, Week 9, Month 6 ]
    assess subjective measures of physical and mental health, pain, and quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03709251

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Contact: Margaret Danilovich, Ph.D. 312-503-7215
Contact: Laura Diaz 312-503-2715

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United States, Illinois
Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences Recruiting
Chicago, Illinois, United States, 60611
Contact: Laura Diaz, BS    312-503-2715   
Sponsors and Collaborators
Northwestern University

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Responsible Party: Margaret Danilovich, Assistant Professor, Northwestern University Identifier: NCT03709251    
Other Study ID Numbers: STU00205686
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes