High Intensity Walking to Reduce Frailty

• Sponsor: Northwestern University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03709251
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty	Behavioral: High Intensity Walking; Behavioral: Casual Speed Walking	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: High Intensity Walking to Reduce Frailty
• Actual Study Start Date: Oct 12, 2018
• Actual Primary Completion Date: Feb 8, 2021
• Actual Study Completion Date: Mar 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Improved mobility as measured by gait speed [Baseline, Week 9, Month 6]

   Measures related to overall health and mobility

2. Improved mobility as measured by 6 Minute Walk Test [Baseline, Week 9, Month 6]

   Measures related to mobility

3. Improved mobility as measured by Time Up and Go [Baseline, Week 9, Month 6]

   Measures related to mobility

4. Improved physical function on the Short Physical Performance Battery [Baseline, Week 9, Month 6]

   Provide an overall assessment of functional status and physical performance

5. 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

6. 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

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Margaret Danilovich, Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT03709251
• Other Study ID Numbers: STU00205686
• First Posted: Oct 17, 2018
• Last Update Posted: Mar 4, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Frailty

Study Results

No Results Posted as of Mar 4, 2021