Phase 3
Completed N=1,635
The LIFE Study - Lifestyle Interventions and Independence for Elders
Sedentary Lifestyle · Risk of Disability · Aging
Source: ClinicalTrials.gov NCT01072500 ↗
Enrolled (actual)
1,635
Serious AEs
47.5%
Results posted
Apr 2016
Primary outcomePrimary: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters — 246; 290 participants — p=0.03
◆ Published Evidence
Highly cited
106citations · ~8 / year
Lifestyle interventions and independence for elders study: recruitment and baseline characteristics.
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.
Linked Publications (5)
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Lifestyle interventions and independence for elders study: recruitment and baseline characteristics.
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Ankle brachial index values, leg symptoms, and functional performance among community-dwelling older men and women in the lifestyle interventions and independence for elders study.
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Promoting physical activity for elders with compromised function: the lifestyle interventions and independence for elders (LIFE) study physical activity intervention.
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The MAT-sf: clinical relevance and validity.
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Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors.
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 |
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
Data sourced from ClinicalTrials.gov (NCT01072500) and the linked publication. 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. Informational only — not medical advice.