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High Intensity Walking to Reduce Frailty

High Intensity Walking to Reduce Frailty

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03709251
Enrollment
59
Registered
2018-10-17
Start date
2018-10-12
Completion date
2021-03-02
Last updated
2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

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.

Interventions

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

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)Baseline, Week 9, Month 6Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity

Secondary

MeasureTime frameDescription
Improved mobility as measured by 6 Minute Walk TestBaseline, Week 9, Month 6Measures related to mobility
Improved mobility as measured by Time Up and GoBaseline, Week 9, Month 6Measures related to mobility
Improved physical function on the Short Physical Performance BatteryBaseline, Week 9, Month 6Provide an overall assessment of functional status and physical performance
Improved mobility as measured by gait speedBaseline, Week 9, Month 6Measures related to overall health and mobility
Monthly self reports of Health Care UtilizationBaseline, Week 9, Month 3, Month 4, Month 5, Month 6Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits
Patient Reported Outcomes Measure Information System (PROMIS) Global HealthBaseline, Week 9, Month 6assess subjective measures of physical and mental health, pain, and quality of life
Improved balance as measured by the Berg Balance ScaleBaseline, Week 9, Month 6The 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026