N/A
Completed N=134
Reducing Falls With RENEW in Older Adults Who Have Fallen
muscle atrophy · Physical Deconditioning
Source: ClinicalTrials.gov NCT01080196 ↗
Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study — 239; 249.67 Days survived without a fall.
Summary
This clinical trial will compare the effects of a high intensity Resistance Exercise via Negative Work (RENEW) vs. Traditional resistance exercise (TRAD) as part of a mult-component exercise and fall-reduction program on muscle conditioning; falling risks; as well as the fall incidence in older adults who have fallen. We anticipate that muscle conditioning will mediate the effect of RENEW on falling risks and fall incidence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study |
239; 249.67 | — |
Eligibility Criteria
Inclusion Criteria
- male or a female at least 65 years of age or older with 2 or more self-reported co-morbid conditions.
- experienced at least 1 fall (defined for this study as unintentionally coming to rest on the ground, floor, or other lower level) in the previous 12 months
- ambulatory, community dwelling with gait speed ranging from of 25m/min to 80m/min
- medically cleared by their physician to participate in a 60 minute (with rests) MCERFP
- capable of performing RENEW on the ergometer (see below)
- recall of all 3 items (or 1-2 items with a normal clock drawing test) on the Mini-Cog instrument for dementia
Exclusion Criteria
- progressive diagnosed neurologic disease (e.g., Parkinson's, multiple sclerosis, Guillain-Barre, Alzheimers)
- any dystrophies or rheumatologic conditions that primarily affects muscle (muscular dystrophy, PMR)
- having already participated in a MCEFRP
- regular (3x/week) aerobic or resistance exercise performed over the past 12 months; "aerobic" defined as hiking, fast-walking, jogging, running swimming or cycling; "resistance" defined as weight training with bands, cable, free-weights or weight-machines
- Any of the following list of absolute contraindications for MRI:
- Cardiac Pacemakers (except in rare, controlled environments)
- Cochlear (inner ear) implants
- Swan-Ganz catheters with thermodilution tips
- Ferromagnetic or unidentifiable aneurysm clips of the brain
- Implanted neuro stimulators
- Metal or unidentifiable foreign bodies in the eyes
- Shrapnel near a vital organ
- Extreme claustrophobia
Data sourced from ClinicalTrials.gov (NCT01080196). 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.