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Cluster randomized trial of reablement strategies targeting sarcopenia (ReStart-S) in long-term care settings
Prabal Kumar1, Shashikiran Umakanth2, Kusumakshi Nayak3
1Department of Physiotherapy, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Background:
Sarcopenia prevalence is high in long-term care settings (LTCS), yet existing guidelines often overlook this population. The Reablement Strategies targeting Sarcopenia (ReStart-S) program was developed to address this gap. This study evaluated its effects on muscle outcomes, physical performance, quality of life (QoL), and a blood biomarker.
Methods:
A cluster-randomized trial was conducted in LTCS across Udupi and neighboring districts. Sarcopenic older adults (≥ 60 years, Barthel Index ≥ 60, Mini-Cog ≥ 3, AWGS-2019 criteria) were recruited. LTCS were randomized into intervention (IG) and control (CG) groups. IG received a 6-week ReStart-S program, while CG continued usual activities. Outcomes at baseline, 6, 12, and 18 weeks included handgrip strength (HGS, primary outcome), skeletal muscle index (SMI), Short Physical Performance Battery (SPPB), SarQoL, and C-terminal Agrin Fragment (CAF; not assessed at 12 weeks). Linear mixed models evaluated group*time interactions with Bonferroni correction.
Results:
Of 12 LTCS screened, 7 were eligible; 78 participants enrolled (IG = 39; CG = 39). CG was older than IG (74.3 ± 9.4 vs 67.9 ± 6.0; p < .001). Significant group*time interaction was observed for HGS (F = 5.524; p = .001), improving at 12 (2.49; 95% CI, 1.16-3.82; p < .001) and 18 weeks (2.14; 0.79-3.48; p = .002). SPPB improved at 6, 12, and 18 weeks (all p < .001). SarQoL improved at all follow-ups (all p < .001). SMI improved at 18 weeks (0.20; p = .011). CAF decreased at 18 weeks (-61.77; p < .001).
Conclusion:
ReStart-S improved muscle strength, physical performance, and QoL, reduced CAF, and showed delayed muscle mass gains, supporting its role in sarcopenia care in LTCS.
Clinical Trial Registration:
The study was prospectively registered on October 20, 2022 on the Clinical Trial Registry-India (CTRI) platform. Trial registration number CTRI/2022/10/046680. The trial can be accessed at: https://ctri.nic.in/Clinicaltrials/showallp.php? mid1=71007&EncHid=&userName=CTRI/2022/10/046680.
