High Intensity Walking to Reduce Frailty

Frailty Clinical Trial

Official title:

High Intensity Walking to Reduce Frailty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03709251
• Other study ID #: STU00205686
• Status: Terminated
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: March 2, 2021

Study information

• Verified date: March 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: March 2, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• High Intensity Walking
Intense walking activity at an intensity of 70-80% of the maximum heart rate
• Casual Speed Walking
Moderate intensity (50-60% of Heart Rate maximum)

Locations

Country	Name	City	State
United States	Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improved mobility as measured by gait speed	Measures related to overall health and mobility	Baseline, Week 9, Month 6
Secondary	Improved mobility as measured by 6 Minute Walk Test	Measures related to mobility	Baseline, Week 9, Month 6
Secondary	Improved mobility as measured by Time Up and Go	Measures related to mobility	Baseline, Week 9, Month 6
Secondary	Improved physical function on the Short Physical Performance Battery	Provide an overall assessment of functional status and physical performance	Baseline, Week 9, Month 6
Secondary	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
Secondary	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
Secondary	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