Mobility and strength training with and without protein supplements for pre-frail/frail older people with low protein intake: maximising mobility and strength training (MMoST) feasibility randomised controlled trial.

The study was not feasible based on the original protocol, with recruitment being the primary challenge.

• The recruitment target was 50 participants, but only 20 participants were randomised.
• 952 older adults were screened across the recruitment period.
• Initial recruitment from existing clinical caseloads failed because 'patients were more unwell and disabled than anticipated and ineligible.'
• No participants were recruited from an existing cohort study.
• The study 'ran out of time to reach our target.'

A community recruitment strategy was implemented as a more efficient alternative to clinical caseload and cohort recruitment.

• Initial recruitment focused on existing NHS community trust physiotherapy caseloads but yielded no eligible participants.
• No participants were recruited from an existing cohort study.
• Community advertising was subsequently implemented as an alternative strategy.
• The authors concluded that community advertising 'requires further refinement' for a future definitive trial.

Good intervention fidelity was achieved for both the exercise and protein supplement interventions.

• The median number of exercise sessions completed was 10.5 out of 16 (IQR 7–13).
• Six participants received protein supplements, which they tolerated well and took regularly.
• All participants undertook twice-weekly mobility and strength training supported by a physiotherapist for 24 weeks.
• The protein supplement arm aimed to increase protein intake up to 1.6 g/kg of body weight/day.

Study retention was 70%, with no difference in retention between trial arms.

• 14 out of 20 participants (70%) attended follow-up assessments.
• There was 'no difference in retention between arms.'
• Follow-up assessments were conducted at 5–8 months.
• Outcome assessors were blinded.

All clinical outcomes showed a trend towards larger improvements in the exercise and protein arm compared to the exercise-only arm, though none were statistically significant.

• Short Physical Performance Battery (SPPB) scores were higher in the exercise and protein arm (mean difference 0.93, 95% CI −2.70 to 4.56).
• 6-Minute Walk Test (6MWT) distances were higher in the exercise and protein arm (mean difference 41.92 m, 95% CI −39.05 to 122.89).
• The authors noted these results 'should be interpreted cautiously' given the small sample size of 20 participants.
• Secondary outcome analyses used linear regression models adjusted for baseline outcome score and frailty status.

The recruited sample comprised predominantly frail older adults with a median age of 76 years.

• Median age of participants was 76 years (IQR 68.5–80.0).
• 15 out of 20 participants (75%) were classified as frail; the remainder were pre-frail.
• Eligible participants were adults aged ≥60 years with walking difficulties or slow walking and low protein intake (<1 g protein/kg body weight/day).
• Recruitment was conducted across four NHS community trust physiotherapy departments.

The trial protocol required participants to have low protein intake, defined as less than 1 g protein/kg body weight/day, as an inclusion criterion.

• Participants were required to have low protein intake (<1 g protein/kgBW/day) at baseline.
• The protein supplement intervention was designed to increase protein intake up to 1.6 g/kgBW/day.
• Participants were also required to be frail or pre-frail and report walking difficulties or slow walking.
• Participants were aged ≥60 years.