Implementing an exercise intervention for sarcopenia in oldest-old nursing home residents: protocol for a pragmatic cluster-randomized controlled trial (SCOPE Study).

The SCOPE study targets a population of nursing home residents aged 75 years or older with sarcopenia, a group largely underrepresented in existing exercise intervention research.

• Existing evidence has largely been generated in selected community-dwelling populations, limiting applicability to vulnerable older adults in real-world long-term care settings.
• The trial aims to recruit 104 residents with sarcopenia from a large nursing home in Hangzhou, China.
• Sarcopenia is described as having 'particularly high prevalence among nursing home residents and the oldest-old population.'
• Participants must be aged ≥75 years and meet diagnostic criteria for sarcopenia.

The trial uses a cluster-randomized design with residential building as the unit of randomization to minimize contamination between intervention groups.

• Participants are randomized by residential building into four groups: Modified Baduanjin Group, Resistance Training Group, Combined Exercise Group, and Control Group.
• The cluster design addresses practical constraints of delivering multiple distinct exercise programs within a single nursing home setting.
• The pragmatic design is intended to reflect real-world long-term care conditions rather than tightly controlled efficacy conditions.
• The trial is registered in the Chinese Clinical Trial Registry (ChiCTR2500107315).

The intervention is 48 weeks in duration and is delivered by trained caregivers using video-guided sessions with phased reduction in specialist supervision.

• The caregiver-led delivery model is designed to enhance feasibility and sustainability in nursing home settings.
• Video-guided sessions are used to standardize the exercise content across intervention groups.
• Specialist supervision is progressively reduced over the course of the intervention (phased reduction), suggesting a transition toward caregiver independence.
• The three active interventions are Modified Baduanjin (a traditional Chinese mind-body exercise), resistance training, and a combined exercise program.

The primary outcome is a composite sarcopenia Z-score integrating handgrip strength, Short Physical Performance Battery (SPPB), and appendicular skeletal muscle mass index (ASMI).

• The composite Z-score approach integrates three key sarcopenia diagnostic components into a single primary endpoint.
• Handgrip strength measures muscle strength, SPPB measures physical performance, and ASMI measures muscle mass.
• This composite outcome is designed to capture the multidimensional nature of sarcopenia.
• Using a Z-score composite allows standardized comparison across measures with different units and scales.

Secondary outcomes encompass a broad multimodal assessment battery including functional, behavioral, neuromuscular, psychological, and biological measures.

• Secondary outcomes include functional mobility, balance, physical activity and sedentary behaviour, and neuromuscular activation.
• Questionnaire-based assessments and saliva biological markers are also included as secondary outcomes.
• Clinical events and care-dependency records will be collected throughout the intervention and follow-up periods.
• The inclusion of saliva biological markers suggests an exploratory investigation into potential biological mechanisms of exercise adaptation.

The trial includes an extended long-term follow-up period of up to two years post-intervention to assess durability of effects.

• Assessments are scheduled at baseline, week 12, week 24, week 48, and at 1 and 2 years post-intervention.
• This follow-up schedule allows evaluation of both short-term and sustained effects of exercise on sarcopenia outcomes.
• The 2-year post-intervention follow-up is notably longer than most existing exercise trials in this population.
• Long-term follow-up data will also capture clinical events and changes in care dependency.

The SCOPE study is designed to inform exercise prescription, implementation feasibility, and potential mechanisms of adaptation in oldest-old nursing home residents.

• The trial aims to 'support the development of scalable exercise intervention frameworks for sarcopenia management in long-term care facilities.'
• By integrating pragmatic caregiver-led delivery with multimodal outcome assessment, the trial addresses both effectiveness and real-world scalability.
• The study explicitly addresses the gap between controlled research settings and real-world long-term care environments.
• The findings are intended to be applicable beyond the single study site to other long-term care facilities.