Background
Objective
Trial design
Methods
Participants, interventions, and outcomes
Study setting
Eligibility criteria
Interventions
Physical activity monitor intervention
Experimental intervention
Fidelity
Outcomes
Primary outcome measure
Secondary outcome measures
International physical activity questionnaire-short form (IPAQ-SF)
Nordic physical activity questionnaire short (NPAQ-short)
The 5-level EuroQol-5 domain (EQ-5D-5L) quality of life questionnaire
UCLA loneliness scale
Self-efficacy for exercise
Outcome expectancy for Exercise-2
Social- and demographic baseline variables
Characteristics | Overall (n=) | Control group (n=) | Intervention group (n=) | p |
---|---|---|---|---|
Age in years, mean (95% CI) | – | – | – | ⨂ |
Male, n (%) | – | – | – | ⊠ |
BMI, mean (95%CI) | – | – | – | ⨂ |
Education | – | – | – | ⊠ |
No education, n (%) | – | – | – | |
Primary or secondary education, n (%) | – | – | – | |
Tertiary education, n (%) | – | – | – | |
Master’s degree, n (%) | – | – | – | |
Living alone, n (%) | – | – | – | ⊠ |
Long-term illness, injuries or disability more than 6 months, n (%) | – | – | – | ⊠ |
Smoking | – | – | – | |
Smokes, n (%) | – | – | – | ⊠ |
Quit smoking, n (%) | – | – | – | |
Never smoked, n (%) | – | – | – | |
Wants to be more physically active | – | – | – | |
Yes, n (%) | – | – | – | ⊠ |
No, n (%) | – | – | – | |
Do not know, n (%) | – | – | – | |
Uses a PAM before enrolment, n (%) | – | – | – | ⊠ |
Walking aids | ||||
No walking aids, n (%) | – | – | – | ⊠ |
Cane user, n (%) | – | – | – | |
Rollator user, n (%) | – | – | – | |
Reports to be in pain, n (%) | – | – | – | ⊠ |
EQ-5D | – | – | – | |
Mobility – reporting problems n (%) | – | – | – | ⊠ |
Self-Care – reporting problems n (%) | – | – | – | ⊠ |
Usual Activity – reporting problems n (%) | – | – | – | ⊠ |
Pain/Discomfort – reporting problems n (%) | – | – | – | ⊠ |
Anxiety/Depression – reporting problems n (%) | – | – | – | ⊠ |
EQ VAS, mean (95%CI) | – | – | – | ⨂ |
UCLA Loneliness Scale, mean n (%) | – | – | – | ⨂ |
OEE average score, mean (95% CI) | – | – | – | ⨂ |
SEE average score, mean (95% CI) | – | – | – | ⨂ |
Characteristics | Overall (n=) | Control group (n=) | Intervention group (n=) | p |
---|---|---|---|---|
Baseline Physical Activity Average daily step count, mean (95% CI) | – | – | – | ⨂ |
IPAQ-SF | – | – | – | |
MVPA, mean (95% CI) | – | – | – | ⨂ |
MPA, mean (95% CI) | – | – | – | ⨂ |
VPA, mean (95% CI) | – | – | – | ⨂ |
Walking time, mean (95% CI) | – | – | – | ⨂ |
Sedentary time, mean (95% CI) | – | – | – | ⨂ |
Low activity level, n (%) | – | – | – | |
Moderate activity level, n (%) | – | – | – | ⊠ |
High activity level, n (%) | – | – | – | |
NPAQ | – | – | – | |
MVPA, mean (95% CI) | – | – | – | ⨂ |
VPA, mean (95% CI) | – | – | – | ⨂ |
Physically inactive, n (%) | – | – | – | |
Insufficient physically active, n (%) | – | – | – | |
Sufficient physically active, n (%) | – | – | – | ⊠ |
Optimally physically active, n (%) | – | – | – |
Sample size and power considerations
Recruitment
Assignment of interventions
Allocation
Data collection, management, and analysis
Data collection methods
Data management
Statistical methods
Characteristics | Control group (n=) | Intervention group (n=) | P |
---|---|---|---|
Primary outcome Average daily step count, mean (95% CI) | – | – | – |
Secondary outcomes | – | – | – |
EQ VAS, mean (95% CI) | – | – | – |
UCLA Loneliness Scale, mean n (%) | – | – | – |
OEE average score, mean (95% CI) | – | – | – |
SEE average score, mean (95% CI) | – | – | – |
IPAQ-SF MVPA, mean (95% CI) | – | – | – |
IPAQ-SF Walking time, mean (95% CI) | – | – | – |
IPAQ-SF Sedentary time, mean (95% CI) | – | – | – |
NPAQ MVPA, mean (95% CI) | – | – | – |