Mobility LimitationTRANS2NCT03083275
Resistance Training in Older Adults With Limitations in Mobility
A study testing Resistance Training in people with Mobility Limitation, run by Tufts University.
Trial summary
The age-related loss in skeletal muscle mass is associated with substantial social and economic costs as evidenced by impairments in strength, limitations in function, and ultimately, physical disability and institutionalization (1-3). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2016to 15 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Willing and able to sign the IRB approved informed consent form.
- Community dwelling
- Male or female subject ≥ 70 years at first contact.
- The subject has a body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive.
- SPPB score ≤9.
- The subject is able to complete >200 meters during the 6-min walk test without an assistive device (single straight cane is acceptable), or the help of another person.
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- Mini-Mental State Examination (MMSE) score >21.
- Participates in moderate-intensity physical activity ≤20 minutes/week.
- Subject agrees not to participate in another interventional or exercise study while participating in the present study, defined as signing the informed consent form, until completion of the last study visit.
Who cannot join
- Nursing home resident
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], and/or total bilirubin [TBil]) above 1.5 times the upper limit of normal at screening.
- Any clinically significant abnormality following the study doctor's review of the physical examination, ECG and protocol defined clinical laboratory tests at screening.
- Serious conduction disorder (eg, third-degree heart block), uncontrolled arrhythmia, or ST-segment depressions (>3 mm) on the ECG at screening.
- Myocardial infarction, major heart surgery (i.e, valve replacement or bypass surgery), stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months prior to screening.
- A pulse < 40 or > 100 bpm; mean systolic blood pressure >160 mm Hg ; mean diastolic blood pressure >100 mmHg (measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically) at screening.
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- Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
- Hemoglobin (Hb) concentration below 10.0 g/dL at screening.
- Approximately >20% weight loss in the previous 3 months prior to screening
- Chronic medications introduced within 2 weeks prior to screening
- Cancer requiring treatment currently or in the past 3 years (except primary non-melanoma skin cancer, carcinoma in situ or cancers that have an excellent prognosis such as early stage breast or prostate cancer)
- Neurological conditions or neuromuscular diseases that cause impaired muscle function or mobility
- Current diagnosis of schizophrenia, other severe psychotic disorders, or severe bipolar disorder.
- Severe and/or uncontrolled medical conditions that could interfere with the study (e.g. severe neurological deficit after stroke, respiratory diseases requiring supplemental oxygen, infection, gastrointestinal disorder, uncontrolled pain, arthritis or any other non-stable illness) as judged by the study doctor that would prevent participation in a resistance training exercise program.
- Cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, uncontrolled atrial fibrillation, presence of an implantable cardiac defibrillator, or uncontrolled angina).
- Surgical procedure requiring general anesthesia within 2 months prior to screening, or a planned surgical procedure requiring general anesthesia during the study period
- Subject is using any medicines, non-medical compounds, or dietary aids/food supplements to improve physical function or muscle mass that have not been at a stable dose for at least 4 weeks prior to screening and/or are anticipated to change dosing regimen during the study.
- The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 5 ounces of wine or 1.5 ounce of spirits/hard liquor).
- Participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives whichever is longer, prior to the initiation of screening.
- The subject has any other condition, which in the opinion of the Investigator, precludes the subject's participation in the trial.
- Employee of the Astellas Group or vendors involved in the study.
About this study
Official title: An Exploratory Study to Evaluate the Relationship Between Measures of Lower-extremity Peak Torque, Velocity, Power, Fatigue, and Measures of Physical Function in Response to Resistance Training in Older Adults With Limitations in Mobility
The age-related loss in skeletal muscle mass is associated with substantial social and economic costs as evidenced by impairments in strength, limitations in function, and ultimately, physical disability and institutionalization (1-3). Improved knowledge of the physiologic mechanisms that mediate impairments in physical functioning is crucial for developing effective therapeutic interventions for preserving mobility and independence among physically frail adults.
To date, pharmacodynamic markers that can be used in a clinical trial in mobility-limited older adults are limited. Lean body mass measured by dual energy X-ray absorptiometry (DXA) is frequently used in early phase clinical development of investigational anabolic drugs. Although increase in muscle mass is considered to contribute to increased muscle strength, this alone does not completely explain changes in physical performance. Thus, more direct pharmacodynamic evidence associated with physical functioning is desired in early phase clinical development decision making. Assessments of muscle power and fatigue can address this need. The use of such assessments may provide more meaningful information as to the pharmacodynamics effects of investigational drugs on muscle parameters.
This study will serve as a validation study, aiming to 1) examine the effect a 12-week resistance program may have on muscle power and fatigue; 2) examine the effect of a 12-week resistance exercise program on conventional measures of muscle function; 3) determine the relationship between muscle power/fatigue and conventional measures of physical function. Data from this study will serve as rationale for potentially including these measures as pharmacodynamics markers in studies of novel therapies for skeletal muscle loss and/or weakness.
Read the detailed description
The age-related loss in skeletal muscle mass is associated with substantial social and economic costs as evidenced by impairments in strength, limitations in function, and ultimately, physical disability and institutionalization (1-3). Improved knowledge of the physiologic mechanisms that mediate impairments in physical functioning is crucial for developing effective therapeutic interventions for preserving mobility and independence among physically frail adults.
To date, pharmacodynamic markers that can be used in a clinical trial in mobility-limited older adults are limited. Lean body mass measured by dual energy X-ray absorptiometry (DXA) is frequently used in early phase clinical development of investigational anabolic drugs. Although increase in muscle mass is considered to contribute to increased muscle strength, this alone does not completely explain changes in physical performance. Thus, more direct pharmacodynamic evidence associated with physical functioning is desired in early phase clinical development decision making. Assessments of muscle power and fatigue can address this need. For example, Bean et al reported that improvements in leg power, independent of strength, appear to make an important contribution to clinically meaningful improvements in SPPB (Short Physical Performance Battery) and gait speed (4). Avin and Frey Law performed a systematic meta-analysis of studies reporting fatigue tasks (voluntary activation) performed at a relative-intensity in both young (18-45 years of age) and old (>54 years of age) healthy adults to conclude older adults were able to sustain relative-intensity tasks significantly longer or with less force decay than younger adults although this age-related difference was present only for sustained and intermittent isometric contractions and this age-related advantage was lost for dynamic tasks (5). The use of such assessments may provide more meaningful information as to the pharmacodynamics effects of investigational drugs on muscle parameters.
This study will serve as a validation study, aiming to 1) examine the effect a 12-week resistance program may have on muscle power and fatigue; 2) examine the effect of a 12-week resistance exercise program on conventional measures of muscle function; 3) determine the relationship between muscle power/fatigue and conventional measures of physical function. Data from this study will serve as rationale for potentially including these measures as pharmacodynamics markers in studies of novel therapies for skeletal muscle loss and/or weakness.
- Conditions
- Mobility Limitation
- Being tested
- Resistance Training
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Experimental | Not described Receives: Other: Resistance Training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of peak torques
Change from baseline in the sum of peak torques from an isokinetic fatigue test
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start3 Jan 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Roger A Fielding, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083275
- Sponsor's protocol ID
- 2890
- Acronym
- TRANS2
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Englund DA, Price LL, Grosicki GJ, Iwai M, Kashiwa M, Liu C, Reid KF, Fielding RA. Progressive Resistance Training Improves Torque Capacity and Strength in Mobility-Limited Older Adults. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1316-1321. doi: 10.1093/gerona/gly199.
PubMed 30165595
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Relationship Between Measures of Lower-extremity Peak Torque, Velocity, Power, Fatigue, and Measures of Physical Function in Response to Resistance Training in Older Adults With Limitations in Mobility
- ClinicalTrials.gov ID
- NCT03083275
- Acronym / sponsor ID
- TRANS2 / 2890
- Conditions
- Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The age-related loss in skeletal muscle mass is associated with substantial social and economic costs as evidenced by impairments in strength, limitations in function, and ultimately, physical disability and institutionalization (1-3). Improved knowledge of the physiologic mechanisms that mediate impairments in physical functioning is crucial for developing effective therapeutic interventions for preserving mobility and independence among physically frail adults.
To date, pharmacodynamic markers that can be used in a clinical trial in mobility-limited older adults are limited. Lean body mass measured by dual energy X-ray absorptiometry (DXA) is frequently used in early phase clinical development of investigational anabolic drugs. Although increase in muscle mass is considered to contribute to increased muscle strength, this alone does not completely explain changes in physical performance. Thus, more direct pharmacodynamic evidence associated with physical functioning is desired in early phase clinical development decision making. Assessments of muscle power and fatigue can address this need. The use of such assessments may provide more meaningful information as to the pharmacodynamics effects of investigational drugs on muscle parameters.
This study will serve as a validation study, aiming to 1) examine the effect a 12-week resistance program may have on muscle power and fatigue; 2) examine the effect of a 12-week resistance exercise program on conventional measures of muscle function; 3) determine the relationship between muscle power/fatigue and conventional measures of physical function. Data from this study will serve as rationale for potentially including these measures as pharmacodynamics markers in studies of novel therapies for skeletal muscle loss and/or weakness.
Detailed description
The age-related loss in skeletal muscle mass is associated with substantial social and economic costs as evidenced by impairments in strength, limitations in function, and ultimately, physical disability and institutionalization (1-3). Improved knowledge of the physiologic mechanisms that mediate impairments in physical functioning is crucial for developing effective therapeutic interventions for preserving mobility and independence among physically frail adults.
To date, pharmacodynamic markers that can be used in a clinical trial in mobility-limited older adults are limited. Lean body mass measured by dual energy X-ray absorptiometry (DXA) is frequently used in early phase clinical development of investigational anabolic drugs. Although increase in muscle mass is considered to contribute to increased muscle strength, this alone does not completely explain changes in physical performance. Thus, more direct pharmacodynamic evidence associated with physical functioning is desired in early phase clinical development decision making. Assessments of muscle power and fatigue can address this need. For example, Bean et al reported that improvements in leg power, independent of strength, appear to make an important contribution to clinically meaningful improvements in SPPB (Short Physical Performance Battery) and gait speed (4). Avin and Frey Law performed a systematic meta-analysis of studies reporting fatigue tasks (voluntary activation) performed at a relative-intensity in both young (18-45 years of age) and old (>54 years of age) healthy adults to conclude older adults were able to sustain relative-intensity tasks significantly longer or with less force decay than younger adults although this age-related difference was present only for sustained and intermittent isometric contractions and this age-related advantage was lost for dynamic tasks (5). The use of such assessments may provide more meaningful information as to the pharmacodynamics effects of investigational drugs on muscle parameters.
This study will serve as a validation study, aiming to 1) examine the effect a 12-week resistance program may have on muscle power and fatigue; 2) examine the effect of a 12-week resistance exercise program on conventional measures of muscle function; 3) determine the relationship between muscle power/fatigue and conventional measures of physical function. Data from this study will serve as rationale for potentially including these measures as pharmacodynamics markers in studies of novel therapies for skeletal muscle loss and/or weakness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Other: Resistance Training |
| Control | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Willing and able to sign the IRB approved informed consent form.
- Community dwelling
- Male or female subject ≥ 70 years at first contact.
- The subject has a body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive.
- SPPB score ≤9.
Key exclusion criteria (21 listed)
- Nursing home resident
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], and/or total bilirubin [TBil]) above 1.5 times the upper limit of normal at screening.
- Any clinically significant abnormality following the study doctor's review of the physical examination, ECG and protocol defined clinical laboratory tests at screening.
- Serious conduction disorder (eg, third-degree heart block), uncontrolled arrhythmia, or ST-segment depressions (>3 mm) on the ECG at screening.
- Myocardial infarction, major heart surgery (i.e, valve replacement or bypass surgery), stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months prior to screening.
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 |
|---|---|---|
| Resistance Training | Other | Resistance Training |
Primary outcome
Sum of peak torques
Time frame: Baseline and 12-weeks
Change from baseline in the sum of peak torques from an isokinetic fatigue test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 30165595Englund DA, Price LL, Grosicki GJ, Iwai M, Kashiwa M, Liu C, Reid KF, Fielding RA. Progressive Resistance Training Improves Torque Capacity and Strength in Mobility-Limited Older Adults. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1316-1321. doi: 10.1093/gerona/gly199.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Mobility Limitation, run by Tufts University.
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 9 inclusion and 21 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 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sum of peak torques (time frame: Baseline and 12-weeks). 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 NCT03083275, 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 17 Mar 2017.