N/A
N=134
Reducing Falls With RENEW in Older Adults Who Have Fallen
Muscle Atrophy · Physical Deconditioning
Bottom Line
View on ClinicalTrials.gov: NCT01080196 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study — 239; 249.67 Days survived without a fall.
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RENEW (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Feb 2014
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 | — |
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.
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.