Reducing Falls With RENEW in Older Adults Who Have Fallen

NCT01080196 | Completed Results DMC

• 2 other identifiers: 26292R01AG031255-01A1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Atrophy; Physical Deconditioning

Keywords

Falling risk; muscle conditioning; muscle size; isometric strength; Incidence in falls

Outcome Measures

Primary Outcomes (1)

• The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study

  12 months

Other Outcomes (4)

• Thigh Lean Tissue Cross Sectional Area (CSA) (cm^2)

  12 months

• Leg Extension Power (W)

  12 months

• Activities Specific Balance Confidence (ABC) (%)

  12 months

Study Arms (2)

RENEW

EXPERIMENTAL

RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a "target" workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.

Behavioral: RENEW

TRADITIONAL

NO INTERVENTION

The TRAD group will perform their lower extremity resistance exercise for 15 minutes per session with isotonic weight machines and cuff weights as part of their multicomponent exercise fall reduction program (MCERFP). The progression of the 3 x/week, 12 week TRAD program will be determined as a relative function of their 1 repetition maximum (1RM) weight that can be lifted in a safe and successful manner. The 1RM will be measured before the 12 week training program and every 2 weeks thereafter. A "target" resistance workload (i.e., weight level) commensurate with 60-70% of the 1RM of the knee and hip extensors will be calculated bi-monthly and 3 sets of 15 repetitions of 3-4 different knee and hip exercises will be used over a 15 minute time period.

Interventions

RENEW BEHAVIORAL

RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a "target" workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE.

RENEW

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Department of Health and Human Services: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Department of Physical Therapy, University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• 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.

  PMID: 28716003 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Dr Paul LaStayo
• Organization: University of Utah

paul.lastayo@health.utah.edu

8019719298

Study Officials

• Paul C Lastayo, PT, PhD

  Department of Physical Therapy, University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: April 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 21, 2022
• Results First Posted: January 10, 2018

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)