High Intensity Walking to Reduce Frailty

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.

Study Overview

• Status: Terminated
• Conditions: Frailty
• Intervention / Treatment: Behavioral: High Intensity Walking; Behavioral: Casual Speed Walking

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Casual Speed Walking; Self selected pace	Behavioral: Casual Speed Walking; Moderate intensity (50-60% of Heart Rate maximum)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, Week 9, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved mobility as measured by gait speed	Measures related to overall health and mobility	Baseline, Week 9, Month 6
Improved mobility as measured by 6 Minute Walk Test	Measures related to mobility	Baseline, Week 9, Month 6
Improved mobility as measured by Time Up and Go	Measures related to mobility	Baseline, Week 9, Month 6
Improved physical function on the Short Physical Performance Battery	Provide an overall assessment of functional status and physical performance	Baseline, Week 9, Month 6
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	Baseline, Week 9, Month 6
Monthly self reports of Health Care Utilization	Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits	Baseline, Week 9, Month 3, Month 4, Month 5, Month 6
Patient Reported Outcomes Measure Information System (PROMIS) Global Health	assess subjective measures of physical and mental health, pain, and quality of life	Baseline, Week 9, Month 6

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): February 8, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: STU00205686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No