Reducing Falls With RENEW in Older Adults Who Have Fallen

Muscle atrophy and weakness accompanying aging contributes greatly to an increased risk and
incidence of falling. Over one-third of individuals 65 years of age or older experience a
fall [1,2]. In a 2006 review [3] of 16 controlled (prospective and retrospective) studies
[4-8] major factors affecting risk were identified with the most influential risk factors
being muscle weakness, and deficits in balance and gait. The rate of muscle de-conditioning
is accelerated by inactivity, muscle disuse and co-morbid conditions [9-12]. Older
individuals with deficits in muscle size, strength and power can become so mobility-limited
that simply walking to the mailbox is at the upper limit of their physical capacity [9]
Hence, improving the muscle conditioning of an elderly individual with high fall risk may
decrease the risk and incidence of falls [13-18]. Muscle conditioning often requires
considerable effort, yet many elderly individuals lack the energetic reserves required for
high-intensity exercise. Consequently, both elderly women and men are caught in a
"downward-spiral" as their muscle de-conditioning accelerates the myriad risks of falling and
the incidence of life-threatening falls.

We have explored the safety and feasibility of a high-intensity Resistance Exercise via
Negative, Eccentrically-induced Work (RENEW) in multiple groups of de-conditioned elderly
males and females, many characterized as being at-risk for a fall due to their impaired
muscle condition, balance, mobility and confidence. Compared to traditional resistance
exercise (TRAD), RENEW is novel and advantageous in that RENEW: is a high-intensity exercise
for muscle, yet requires little effort (resulting in high levels of adherence); induces
unprecedented muscle conditioning (size, strength and power); and lowers falling risks
(balance, mobility and confidence) [19-23]. This study is unique and timely because it is
unknown if RENEW's amplified muscle conditioning translates to a decreased incidence of
falls, particularly for those at the highest risk for an injurious fall, i.e. those who have
fallen. Further, RENEW's long-term sustainability has not been explored.

This clinical trial will compare the effects of RENEW vs. TRAD as part of a multi-component
exercise and fall-reduction program (MCEFRP) on muscle conditioning (muscle size, strength,
power); falling risks (balance, mobility and confidence); as well as the fall incidence. We
anticipate that muscle conditioning will mediate the effect of RENEW on falling risks and
fall incidence. As well, the sustained benefit of RENEW will be explored.

Objective #1: Test whether RENEW's effect is different than TRAD's effect on muscle
conditioning, i.e., muscle size, strength and power.

• H1a: RENEW will result in greater increases (relative to TRAD) in whole muscle volume,
isometric strength and concentric power of the leg extensor muscles, specifically the
quadriceps.

Objective #2: Test whether the effects of RENEW on falling risks is mediated by muscle
conditioning.

- H2a: RENEW will decrease falling risks (impaired balance, mobility and confidence) more
than TRAD.

- H2b: RENEW's effects on falling risks will be mediated by greater muscle conditioning.

Objective #3: Determine if RENEW lowers fall incidence more than TRAD.

• H3a: The RENEW intervention will result in a lower fall incidence (falls and near falls)
than TRAD via the direct influence on muscle conditioning and via the indirect influence of
decreasing falling risks.

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