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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