Phase 2
Completed N=289
The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
Source: ClinicalTrials.gov NCT02676466 ↗Enrolled (actual)
289
Serious AEs
24.9%
Results posted
Sep 2019
Primary outcomePrimary: Changes in the Interleukin-6 Level Between Groups — 0; -0.1; -0.6; 3.8 pg/ml
Summary
ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Interleukin-6 Level Between Groups |
0; -0.1; -0.6; 3.8; -0.3; -0.2 | — |
| PRIMARY Number of Participants Experiencing Major Mobility Disability |
20; 5; 4; 15; 4; 3 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
8.6; 8.1; 8.2; 8.4; 8.6; 7.3 | — |
| SECONDARY Number of Participants Exhibiting Frailty |
15; 3; 4; 1; 3; 3 | — |
| SECONDARY Isometric Hand Grip Strength |
24.8; 25.3; 25.9; 27.5; 22.4; 19.8 | — |
| SECONDARY Peak Torque of the Knee Extensor and Flexor Muscles |
81.3; 77.7; 87.6; 78.6; 85.3; 76.6 | — |
| SECONDARY Short Form Health Survey (SF-36) - Physical Component Score |
41.9; 42.6; 41.8; 41.3; 41.9; 42.7 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women age >70 years
- Self-reported difficulty walking ¼ of a mile or climbing a flight of stairs
- Walking speed 0.44 meters per second on the 4 meter walk at usual pace. A walking speed of 0.44 meters per second)
- Able to complete the 400 meter walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
- Blood level IL-6 >2.5 pg/ml and 14 drinks per week); drug addiction; treatment for cancer (radiation or chemotherapy) within the past 1 year; or other conditions
- Lives outside of the study site or is planning to move out of the area in next 1 year or leave the area for >3 months during the next year
- Exclusion criteria that apply only to those who receive losartan:
- Intolerance or allergy to Angiotensin II Receptor Blockers (ARBs)
- Known bilateral renal artery stenosis or liver cirrhosis
- Hypotension Systolic Blood Pressure 2 servings per week on average
- History of paroxysmal or persistent atrial fibrillation
- To maintain blinding, those who are not eligible to receive any active treatment (ω-3 or losartan) are excluded
Temporary exclusion criteria
- Myocardial infarction, coronary artery bypass grafting (CABG), or valve replacement within past 6 months;
- Pulmonary embolism or deep venous thrombosis within past 6 months;
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
- Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months;
- Physical therapy for gait, balance, or other lower extremity training within the past 2 months;
- Severe hypertension, e.g., Systolic Blood Pressure > 200, or Diastolic Blood Pressure> 110 mmHg;
- Hemoglobin twice upper limit of normal to exclude participants with impaired liver function
- Exclusion criteria that apply only to those who receive ω-3:
- Use of ω-3 within 2 months
Data sourced from ClinicalTrials.gov (NCT02676466). 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.