Clinical trial NCT01080196: Reducing Falls With RENEW in Older Adults Who Have Fallen
Official title: Reducing Falls With RENEW in Older Adults Who Have Fallen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Atrophy
Physical Deconditioning
Keywords: Falling risk
muscle conditioning
muscle size
isometric strength
Incidence in falls
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2010-03-03
Enrollment: 134
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Thigh Lean Tissue Cross Sectional Area (CSA) (cm^2)
timeFrame: 12 months
measure: Leg Extension Power (W)
timeFrame: 12 months
measure: Activities Specific Balance Confidence (ABC) (%)
timeFrame: 12 months
measure: Six Minute Walk (6 MW) Test
timeFrame: 12 months
Locations:
city: Salt Lake City
country: United States
facility: Department of Physical Therapy, University of Utah
state: Utah
Study officials:
affiliation: Department of Physical Therapy, University of Utah
name: Paul C Lastayo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LaStayo P, Marcus R, Dibble L, Wong B, Pepper G. Eccentric versus traditional resistance exercise for older adult fallers in the community: a randomized trial within a multi-component fall reduction program. BMC Geriatr. 2017 Jul 17;17(1):149. doi: 10.1186/s12877-017-0539-8.