Mobility LimitationNCT01614392
Lower Extremity Muscle and Function in the Elderly: Study 2
A study testing High velocity low force Power Training and Low velocity high force Power Training in people with Mobility Limitation, run by Tufts University at 1 site in United States.
Trial summary
This research study is looking to compare the effects of two uniquely different power training interventions (high force, lower velocity versus low force, high velocity) on changes in mobility status among older individuals at risk for mobility disability. Read more about this study
- Who is it for?
- Ages 70 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- High velocity low force Power Training and Low velocity high force Power Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2011
- 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 70 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male and Female 70-85 yrs
- Community dwelling
- Short Performance Battery Score >9
- BMI range 19-32 kg/m2
- Willingness to be randomized and come the laboratory for 20 weeks.
Who cannot join
- Acute or Terminal Illness
- MI in previous 6 months, symptomatic coronary artery disease or congestive heart failure.
- Upper or Lower extremity fracture in previous 6 months
- Uncontrolled hypertension (150/90mmHg)
- Neuromuscular diseases and drugs that affect neuromuscular function
- Hormone replacement therapy
- Participation in any regular endurance or resistance training exercise during previous 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
This research study is looking to compare the effects of two uniquely different power training interventions (high force, lower velocity versus low force, high velocity) on changes in mobility status among older individuals at risk for mobility disability.
- Conditions
- Mobility Limitation
- Being tested
- High velocity low force Power Training, Low velocity high force Power Training
- Keywords
- Resistance Exercise, Physical Activity, Mobility disability, Physical function, Muscle Strength, Older Adults, Mobility-Limited, Peak power and strength
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High velocity low force Power TrainingBehavioural
Lower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
Low velocity high force Power TrainingBehavioural
Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
| Study group | Role | What they receive |
|---|---|---|
| High velocity low force Power Training | Experimental | Lower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). Receives: Behavioral: High velocity low force Power Training |
| Low velocity high force Power Training | Experimental | Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). Receives: Behavioral: Low velocity high force Power Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Extensor Muscle Power
Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.
Measured: Change from baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionOct 2011
- Study completionOct 2011
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.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger A Fielding, Tufts University
- Investigators
- Roger A Fieilding, Ph D., Principal investigator, Jean Mayer USDA Human Nutrition Research Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614392
- Sponsor's protocol ID
- AG-18844
- Status last verified
- Dec 2018
- First submitted
- 28 Sep 2009
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremity Muscle and Function in the Elderly: Study 2
- ClinicalTrials.gov ID
- NCT01614392
- Acronym / sponsor ID
- AG-18844
- Conditions
- Mobility Limitation
- Keywords
- Resistance Exercise, Physical Activity, Mobility disability, Physical function, Muscle Strength, Older Adults, Mobility-Limited, Peak power and strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 10 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is looking to compare the effects of two uniquely different power training interventions (high force, lower velocity versus low force, high velocity) on changes in mobility status among older individuals at risk for mobility disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High velocity low force Power Training | Experimental | Behavioral: High velocity low force Power TrainingLower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). |
| Low velocity high force Power Training | Experimental | Behavioral: Low velocity high force Power TrainingLower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male and Female 70-85 yrs
- Community dwelling
- Short Performance Battery Score >9
- BMI range 19-32 kg/m2
- Willingness to be randomized and come the laboratory for 20 weeks.
Key exclusion criteria (7 listed)
- Acute or Terminal Illness
- MI in previous 6 months, symptomatic coronary artery disease or congestive heart failure.
- Upper or Lower extremity fracture in previous 6 months
- Uncontrolled hypertension (150/90mmHg)
- Neuromuscular diseases and drugs that affect neuromuscular function
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 |
|---|---|---|
| High velocity low force Power TrainingLower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). | Behavioural | High velocity low force Power Training |
| Low velocity high force Power TrainingLower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions). | Behavioural | Low velocity high force Power Training |
Primary outcome
Leg Extensor Muscle Power
Time frame: Change from baseline to Week 16
Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mobility Limitation
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Knee Osteoarthritis
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Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
ACL Reconstruction
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Randomized Clinical Trial to Improve Mobility After Hospitalization
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Active, not recruitingObservational study
Effects of External Upper Limb Loading on Gait and Trunk Muscle Activity in Cardiac Rehabilitation Patients
Cardiovascular Diseases, Cardiac Rehabilitation
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.
Roger A Fieilding, Ph D. principal investigator
Jean Mayer USDA Human Nutrition Research Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High velocity low force Power Training and Low velocity high force Power Training in people with Mobility Limitation, run by Tufts University 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 5 inclusion and 7 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 10 Dec 2018. 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 Dec 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?
Leg Extensor Muscle Power (time frame: Change from baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2018.