Muscle AtrophyNCT01080196
Reducing Falls With RENEW in Older Adults Who Have Fallen
A study testing RENEW in people with Muscle Atrophy and Physical Deconditioning, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Muscle Atrophy, Physical Deconditioning
- What is being tested?
- RENEW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Physical Therapy, University of Utah
Salt Lake City, Utah, 84108
About this study
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.
Read the 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.
- Conditions
- Muscle Atrophy, Physical Deconditioning
- Being tested
- RENEW
- Keywords
- Falling risk, muscle conditioning, muscle size, isometric strength, Incidence in falls
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENEWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startApr 2008
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Paul LaStayo, University of Utah
- Investigators
- Paul C Lastayo, PT, PhD, Principal investigator, Department of Physical Therapy, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080196
- Sponsor's protocol ID
- 26292
- Other IDs
- R01AG031255-01A1
- Status last verified
- May 2022
- First submitted
- 2 Mar 2010
- Last updated
- 21 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28716003
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Falls With RENEW in Older Adults Who Have Fallen
- ClinicalTrials.gov ID
- NCT01080196
- Acronym / sponsor ID
- 26292
- Conditions
- Muscle Atrophy, Physical Deconditioning
- Keywords
- Falling risk, muscle conditioning, muscle size, isometric strength, Incidence in falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Apr 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Posted 10 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RENEW | Experimental | Behavioral: RENEWRENEW 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. |
| 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. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RENEWRENEW 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. | Behavioural | RENEW |
Primary outcome
The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28716003LaStayo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul C Lastayo, PT, PhD principal investigator
Department of Physical Therapy, University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENEW in people with Muscle Atrophy and Physical Deconditioning, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Days Survived Without a Fall Over the 1 Year Duration of the Study (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.