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Table 2 Summary of outcomes, hypotheses, outcome measures, and methods of analysis

From: Measuring the implementation of a group-based Lifestyle-integrated Functional Exercise (Mi-LiFE) intervention delivered in primary care for older adults aged 75 years or older: a pilot feasibility study protocol

Outcomes Hypotheses Outcome measures Methods of analysis
Feasibility
 Recruitment Recruit ≥30 individuals over 6 months • No. of participants recruited over 6 months Descriptive statistics and estimates based on 95 % CI
 Retention Retain ≥75 % of our sample • No. of participants who complete study visit 2 Descriptive statistics and estimates based on 95 % CI
 Adherence ≥50 % of participants will complete exercises ≥3 d/week at 6 months • Proportion of participants that complete exercises ≥3 d/week at 6 months Descriptive statistics and estimates based on 95 % CI
Change in patient-centered outcome measures
 PA levels Improvement from baseline to 6-month follow-up • Moderate-to-vigorous, light, and sedentary activity via accelerometer Paired t test
   • IPAQ  
 Physical performance Improvement from baseline to 6-month follow-up • Composite SPPB score Paired t test
   • Gait speed over 4 m  
   • Standing balance tests from SPPB  
   • Five-Times-Sit-to-Stand  
 QOL Improvement from baseline to 6-month follow-up • EuroQOL EQ5D-3L dimensions Paired t test
   • Visual analogue scale QOL score  
 Eating habits Improvement from baseline to 6-month follow-up • TFEQ-R21 Items- subscale scores Paired t test
 Falls   • No. of self-reported falls on daily diary Descriptive statistics and estimates based on 95 % CI
• No. of fallers
 Harms   • Self-report no. of harms Descriptive statistics and estimates based on 95 % CI
• No. of injuries and hospital visits
 Physician/nurse acceptance   • No. of physicians/nurses that refer potential participants Descriptive statistics and estimates based on 95 % CI
 Barriers and facilitators to implementation   • Log filled out by research staff, clinicians, and participants Thematic content analysis
 Participant satisfaction with intervention   • Semi-structured interview Thematic content analysis
 Fidelity   • Fidelity evaluation of video-taped exercise sessions Rating of compliance and descriptive feedback
  1. PA physical activity, IPAQ International Physical Activity Questionnaire, SPPB short physical performance battery, QOL quality of life