Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT03458793
Eligibility Criteria:
Inclusion Criteria:
1. community-dwelling older adults aged 60 years and older as defined according to the United Nations standard numerical criterion (World Health Organization, 2016);
2. previously sedentary (i.e. engaged in less than 20 minutes per week of regular physical activity for the past month and \< 125 minutes/week of moderate intensity physical activity) (Stevens et al., 1998). Moderate intensity activity that is noticeable accelerates the heart rate and is equal to approximately 3-6 metabolic equivalents (METs) (American College of Sports Medicine, 2013);
3. at risk of feeling socially isolated or lonely (indicated by a score of 6 or higher out of 9) on the 3-item loneliness scale for the phone screening by Hughes et al. (2004) (Appendix 1 - Phone-based eligibility screening form);
4. physically mobile as measured using the Short Physical Performance Battery (SPPB) (Guralnik et al., 1994) with a score ≥ 9 out of 12 (Pahor et al., 2014);
5. healthy or having one or more common chronic diseases but ambulatory;
6. without a cognitive disability as assessed by the Montreal Cognitive Assessment (MOCA) (Nasreddine et al., 2005) with a score ≥ 22 out of 30 (Freitas et al., 2013);
7. able to give written informed consent;
8. English speaking and able to complete paper and pencil questionnaires.
Exclusion Criteria:
1. not community-dwelling older adults 60 years or over;
2. not previously sedentary;
3. currently taking part in another physical activity intervention;
4. not at risk for feeling socially isolated or lonely (i.e. score of less than 6 (out of 9) on the 3-item loneliness scale for the phone screening by Hughes et al., (2004);
5. moderate to severe cognitive disability or clinical diagnosis of dementia;
6. physical disability (i.e. SPPB score less than 9);
7. severe frailty or any chronic health condition that precludes participation in the physical activity intervention and significantly limits the physical mobility of the participant (i.e. hospital settings/ non-ambulatory regime);
8. cognitive disability (i.e. less than 14 points on MOCA);
9. not able to give written informed consent;
10. not English speaking that precludes taking pen and paper tests.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03458793
Study Brief:
Protocol Section:
NCT03458793