High Intensity Walking to Reduce Frailty

NCT03709251 | Terminated

• 1 other identifier: STU00205686
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

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

  Baseline, Week 9, Month 6

Secondary Outcomes (7)

• Improved mobility as measured by gait speed

  Baseline, Week 9, Month 6

• Improved mobility as measured by 6 Minute Walk Test

  Baseline, Week 9, Month 6

• Improved mobility as measured by Time Up and Go

  Baseline, Week 9, Month 6

• Improved physical function on the Short Physical Performance Battery

  Baseline, Week 9, Month 6

• Improved balance as measured by the Berg Balance Scale

  Baseline, Week 9, Month 6

Study Arms (2)

High Intensity Walking

EXPERIMENTAL

HIW (70-80% Heart Rate max)

Behavioral: High Intensity Walking

Casual Speed Walking

EXPERIMENTAL

Self selected pace

Behavioral: Casual Speed Walking

Interventions

High Intensity Walking BEHAVIORAL

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

High Intensity Walking

Casual Speed Walking BEHAVIORAL

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

Casual Speed Walking

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 17, 2018
• Study Start: October 12, 2018
• Primary Completion: February 8, 2021
• Study Completion: March 2, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Locations

US (1)