PRIMA
Trial question
What's the effect of adding timing and coordination training to a standard strength and endurance training in community-dwelling older adults?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
65.0% female
35.0% male
N = 249
249 patients (163 female, 86 male).
Inclusion criteria: ambulatory adult patients aged ≥ 65 years with a gait speed of 0.60-1.20 m/s and physical clearance to exercise.
Key exclusion criteria: dyspnea at rest or during activities; unstable medical condition; dementia or cognitive impairment; history of stroke; plans to leave the area during the study period.
Interventions
N=124 standard-plus program (standard program plus task-specific timing and coordination training).
N=125 standard program (physical therapist-supervised strength, endurance, and flexibility program for 50-60 min twice/week for 12 weeks).
Primary outcome
Mean improvement in gait speed at 12 weeks
0.079 m/s
0.081 m/s
0.1 m/s
0.1 m/s
0.0 m/s
0.0 m/s
0.0 m/s
Standard-plus
program
Standard
program
No significant
difference ↔
No significant difference in mean improvement in gait speed at 12 weeks (0.079 m/s vs. 0.081 m/s; MD 0.001, 95% CI -0.02 to 0.02).
Secondary outcomes
No significant difference in mean improvement in gait speed at 36 weeks (0.059 m/s vs. 0.065 m/s; MD -0.003, 95% CI -0.04 to 0.03).
No significant difference in mean improvement in lower extremity strength at 24 weeks (-2.2 N vs. 2 N; MD -4.9, 95% CI -14.09 to 4.29).
No significant difference in mean improvement in 6 minute walk distance at 24 weeks (31.8 m vs. 20.6 m; MD 7.3, 95% CI -12.1 to 26.7).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In ambulatory adult patients aged ≥ 65 years with a gait speed of 0.60-1.20 m/s and physical clearance to exercise, standard-plus program was not superior to standard program with respect to mean improvement in gait speed at 12 weeks.
Reference
Jennifer S Brach, Subashan Perera, Valerie Shuman et al. Effect of Timing and Coordination Training on Mobility and Physical Activity Among Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212921.
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