Clinical trial NCT03709251: High Intensity Walking to Reduce Frailty
Official title: High Intensity Walking to Reduce Frailty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frailty
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)
timeFrame: Baseline, Week 9, Month 6
Secondary outcomes:
measure: Improved mobility as measured by gait speed
timeFrame: Baseline, Week 9, Month 6
measure: Improved mobility as measured by 6 Minute Walk Test
timeFrame: Baseline, Week 9, Month 6
measure: Improved mobility as measured by Time Up and Go
timeFrame: Baseline, Week 9, Month 6
measure: Improved physical function on the Short Physical Performance Battery
timeFrame: Baseline, Week 9, Month 6
measure: Improved balance as measured by the Berg Balance Scale
timeFrame: Baseline, Week 9, Month 6
measure: Monthly self reports of Health Care Utilization
timeFrame: Baseline, Week 9, Month 3, Month 4, Month 5, Month 6
measure: Patient Reported Outcomes Measure Information System (PROMIS) Global Health
timeFrame: Baseline, Week 9, Month 6
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
state: Illinois
Study officials:
References: