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TerminatedNCT03709251Updated Mar 4, 2021

High Intensity Walking to Reduce Frailty

An interventional study of High Intensity Walking and Casual Speed Walking in Frailty, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to COVID-19 safety precautions and public health guidelines, the study was terminated early.
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Frailty

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03

In context

Frailty

1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.

This study's enrollment of 59 is below the median of 80 across 681 interventional studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    High Intensity Walking

    HIW (70-80% Heart Rate max)

    Behavioral: High Intensity Walking

  • Experimental
    Casual Speed Walking

    Self selected pace

    Behavioral: Casual Speed Walking

Interventions

  • BehavioralHigh Intensity Walking

    Intense walking activity at an intensity of 70-80% of the maximum heart rate

  • BehavioralCasual Speed Walking

    Moderate intensity (50-60% of Heart Rate maximum)

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline, Week 9, Month 6

Secondary outcomes

  1. Improved mobility as measured by gait speed

    Measures related to overall health and mobility

    Time frame: Baseline, Week 9, Month 6

  2. Improved mobility as measured by 6 Minute Walk Test

    Measures related to mobility

    Time frame: Baseline, Week 9, Month 6

  3. Improved mobility as measured by Time Up and Go

    Measures related to mobility

    Time frame: Baseline, Week 9, Month 6

  4. Improved physical function on the Short Physical Performance Battery

    Provide an overall assessment of functional status and physical performance

    Time frame: Baseline, Week 9, Month 6

  5. Improved balance as measured by the Berg Balance Scale

    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

    Time frame: Baseline, Week 9, Month 6

  6. Monthly self reports of Health Care Utilization

    Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits

    Time frame: Baseline, Week 9, Month 3, Month 4, Month 5, Month 6

  7. Patient Reported Outcomes Measure Information System (PROMIS) Global Health

    assess subjective measures of physical and mental health, pain, and quality of life

    Time frame: Baseline, Week 9, Month 6

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Study locations

1 site
  • Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03709251
Lead sponsor
Northwestern University
Responsible party
Margaret Danilovich (Assistant Professor, Northwestern University) — Principal investigator
First posted
Oct 17, 2018
Start date
Oct 12, 2018
Primary completion
Feb 8, 2021
Completion
Mar 2, 2021
Last update
Mar 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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