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Resistance Training in Older Adults With Limitations in Mobility

NCT03083275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-03-17

No results posted yet for this study

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). 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.

Conditions

  • Mobility Limitation

Interventions

OTHER

Resistance Training

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Tufts University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-03
Primary Completion
2017-02-15
Completion
2017-02-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083275 on ClinicalTrials.gov