High Intensity Walking to Reduce Frailty

Not Applicable

Terminated

• Conditions: Frailty
• Interventions: Behavioral: High Intensity Walking; Behavioral: Casual Speed Walking

• Registration Number: NCT03709251
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-10-12
• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Primary Completion: 2021-02-08
• Status Verified: 2021-03
• Study Completion: 2021-03-02
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Intensity Walking	High Intensity Walking	HIW (70-80% Heart Rate max)
Casual Speed Walking	Casual Speed Walking	Self selected pace

Primary Outcome Measures

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

Name	Time	Method
Improved mobility as measured by 6 Minute Walk Test	Baseline, Week 9, Month 6	Measures related to mobility
Monthly self reports of Health Care Utilization	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
Improved mobility as measured by Time Up and Go	Baseline, Week 9, Month 6	Measures related to mobility
Improved balance as measured by the Berg Balance Scale	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
Improved mobility as measured by gait speed	Baseline, Week 9, Month 6	Measures related to overall health and mobility
Patient Reported Outcomes Measure Information System (PROMIS) Global Health	Baseline, Week 9, Month 6	assess subjective measures of physical and mental health, pain, and quality of life
Improved physical function on the Short Physical Performance Battery	Baseline, Week 9, Month 6	Provide an overall assessment of functional status and physical performance

Trial Locations

Locations (1)

Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences; 🇺🇸 Chicago, Illinois, United States