Reducing Falls With RENEW in Older Adults Who Have Fallen

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Utah.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Paul LaStayo, University of Utah
ClinicalTrials.gov Identifier:
NCT01080196
First received: March 2, 2010
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

This phase II 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.


Condition Intervention Phase
Muscle Atrophy
Falls
Other: RENEW vs TRAD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Falls With RENEW in Older Adults Who Have Fallen

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Incidence of falls [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quadriceps volume, strength and power [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RENEW Other: RENEW vs TRAD
Subjects perform lower body resistance exercise via the RENEW protocol or via a "standard of care" protocol
Active Comparator: TRADITIONAL Other: RENEW vs TRAD
Subjects perform lower body resistance exercise via the RENEW protocol or via a "standard of care" protocol

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 phase II 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

Ages Eligible for Study:   65 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080196

Contacts
Contact: Sheldon B Smith, MS, CDE 801-581-6696 sheldon.smith@hsc.uah.edu

Locations
United States, Utah
Department of Physical Therapy, University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Sheldon B Smith, MS, CDE    801-581-6696    sheldon.smith@hsc.utah.edu   
Principal Investigator: Paul C. LaStayo, PT, PhD         
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Paul C Lastayo, PT, PhD Department of Physical Therapy, University of Utah
  More Information

No publications provided

Responsible Party: Paul LaStayo, Primary Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01080196     History of Changes
Other Study ID Numbers: 26292, R01AG031255-01A1
Study First Received: March 2, 2010
Last Updated: June 12, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Utah:
Falling risk
muscle conditioning
whole muscle volume
isometric strength and concentric power
Incidence in falls following a 3 month multi-component fall reduction exercise program

Additional relevant MeSH terms:
Muscular Atrophy
Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014