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The PASSWORD Study – Promoting Safe Walking

Promoting safe walking among older people: Physical and cognitive training intervention among older community-dwelling sedentary men and women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52388040
Enrollment
310
Registered
2017-01-20
Start date
2017-02-02
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedentary lifestyle, risk of mobility disability and falls, aging Signs and Symptoms

Interventions

Participants are randomised to one of two groups using a computer-generated random allocation sequence of two-fold stratification by gender and age (70-74, 75-79, 80-85) with blocks of 20. Physical T

Sponsors

University of Jyväskylä
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 70 to 85 years 2. Community-dwelling 3. Sedentary lifestyle (modified 08/11/2017: sedentary or at most moderately physically active lifestyle) 4. Ability to walk 500 m without assistance (cane is allowed) 5. Willingness to participate 6. MMSE=>24

Exclusion criteria

Exclusion criteria: 1. Unable or unwilling to give informed consent or accept randomization in either study group 2. Current consumption of more than 7 (women) or 14 (men) portions of alcohol per week 3. Another member of the household is a participant in the PASSWORD -study 4. Medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol 5. Underlying Diseases Likely to Limit Lifespan and/or Affect the Safety of the Interventions 6. Cognitive impairment (abnormal CERAD score) or disease affecting cognition (e.g. Altzheimers disease, MCI, dementia) 7. Severe arthritis (either osteoarthritis or rheumatoid arthritis) 8. Cancer requiring treatment in the past year, except for basalioma or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer) 9. Lung disease requiring either regular use of corticosteroid pills or injections or the use of supplemental oxygen 10. Cardiovascular disease (including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history or cardiac arrest, uncontrolled angina) 11. Severe parkinson's disease or other serious neurological disorder 12. Renal disease requiring dialysis 13. Type I or II diabetes with insulin medication 14. Epilepsy with regular medication and seizures during the last year 15. Stroke or cerebral haemorrhage with complications (e.g. hemiplegia) 16. Severe musculoskeletal pain; osteoporosis with fragility fracture history 17. Psychotic disorders (e.g. schizophrenia, bipolar disorder, severe depression) 18. Difficulty in communication with study personnel due to vision or hearing problems

Design outcomes

Primary

MeasureTime frame
10-m maximal walking speed is measured by photocells at baseline, 6 and 12 months.

Secondary

MeasureTime frame
1. 6-min walking distance is measured by a stop watch at baseline, 6 and 12 months 2. Dual-task cost in walking speed is measured over a 20 m track with a visuospatial cognitive task at baseline, 6 and 12 months 3. Fall incidence is measured by monthly falls calendar during the intervention and 1 year follow-up there after 4. Executive functioning is measured using the stroop test and trail making A and B at baseline, 6 and 12 months Other measures: 1. Overall health is assessed during nurses and physicians examinations (GDS, vision, orthostatic test, diseases and medication, resting EKG, blood samples for Hb, blood count, CRP, IGF-1, BDNF, metabolomics) at baseline and 12 months 2. Body composition is assessed using DXA at baseline and 12 months 3. Self-reported difficulty in walking outdoors, 500 m and 2 km is assessed using a questionnaire at baseline, 6 and 12 months 4. Life-space is assessed using a Life-space questionnaire at baseline, 6 and 12 months 5. Global cognitive function (CERAD total score) is assessed at baseline and 12 months 6. Verbal fluency is assessed using a verbal fluency test at baseline, 6 and 12 months 7. Injurious falls is assessed using a monthly falls calendar during the intervention and 1 year follow-up there after 8. Postural balance and lower extremity function is assessed using a Short Physical Performance Battery (SPPB) at baseline and 12 months 9. Level of physical activity is assessed through self-reporting and use of an accelerometer at baseline, 6 and 12 months 10. Fall-related self-efficacy is measured using the Fall-related self-efficacy (FES-I) questionnaire at baseline, 6 and 12 months 11. Sense of coherence (SOC) is measured by a SOC questionnaire at baseline and 12 months 12. Brain function is measured using Magneto Encephalon Graph recordings for a sub-group of 40 participants at baseline and 12 months Added 08/11/2017: 13. Isometric knee extension and grip strength are measured at baseline and 12 months 14. Lower

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026