Phase 3 N=1,635 Randomized Single-blind Prevention

The LIFE Study - Lifestyle Interventions and Independence for Elders

Sedentary Lifestyle · Risk of Disability · Aging

Bottom Line

View on ClinicalTrials.gov: NCT01072500 ↗

Enrolled (actual)

1,635

Serious AEs

47.5%

Results posted

Apr 2016

Primary outcome: Primary: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters — 246; 290 participants — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Physical Activity (Behavioral); Successful Aging (Behavioral)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Major Mobility Disability, Defined as Incapacity to Walk 400 Meters	246; 290	0.03 sig
SECONDARY Persistent Mobility Disability (Assessed Every 6 Months)	120; 162	0.006 sig

Summary

Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years. The primary aim was to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m.

Eligibility Criteria

Inclusion Criteria

age 70 to 89 years; (2) summary score 200 mmHg and/or diastolic blood pressure > 110 mmHg).
Uncontrolled diabetes with recent weight loss, diabetic coma or frequent insulin reactions.
Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months.
Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG.
Myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months.
Undergoing physical therapy or cardiopulmonary rehabilitation
Currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01072500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.