Resistance Training in Older Adults With Limitations in Mobility — TRANS2  

Mobility Limitation Clinical Trial

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

Status Completed

Clinical 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). 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mobility Limitation

• NCT number: NCT03083275
• Study type: Interventional
• Source: Tufts University
• Status: Completed
• Phase: N/A
• Start date: January 3, 2016
• Completion date: February 15, 2017