The PASSWORD Study – Promoting Safe Walking

• Register: ISRCTN
• Last refreshed on: 13 November 2023
• Main ID: ISRCTN52388040
• Date of registration: 20/01/2017
• Prospective Registration: Yes
• Primary sponsor: University of Jyväskylä
• Public title: The PASSWORD Study – Promoting Safe Walking
• Scientific title: Promoting safe walking among older people: Physical and cognitive training intervention among older community-dwelling sedentary men and women
• Date of first enrolment: 02/02/2017
• Target sample size: 310
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN52388040
• Study type: Interventional
• Study design: Single-centre single (assessor) blinded parallel-group randomized controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Finland

Contacts

• Name: Sarianna Sipilä

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 Training (PT) group: Participants receive the multicomponent physical training (PT). This involves undertaking 1-2 supervised sessions of 30 to 45 minutes per week involving walking exercises and progressive resistance and balance training and home exercises. Each participant will attend once a week in supervised walking session. The target intensity will be 13 (moderate value) on the Borg scale. In addition, participants will be advised to walk on their own in order to attain in total 150 min per week by the end of the study. Supervised resistance and balance training will take place once a week in senior gyms. Each training session will include progressive balance training followed by progressive resistance training aiming to improve strength and power for the lower extremity muscles. The training will be performed by pneumatic resistance training machines with SmartCard Software which stores performed workload, sets, reps, and exercise time during each visit. In addition, participants will get a home exercise program including simple balance and functional exercises. The home exercises program is advised to be done 2-3 times/week.

Physical and Cognitive Training (PTCT) group: Participants receive the multicomponent physical training (PT) and a cognitive computer-based training (CT). This involves taking part in PT (as in Physical Training part) and 1-2 supervised cognitive training sessions of 15-20 minutes per week. Progressive cognitive training will include exercises on a computer which target working memory and different components of executive functions. In addit

Primary Outcome(s)

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

Secondary Outcome(s)

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 body extension power is measured using the Nottingham power rig at baseline and 12 months
15. Level of sedentary behavior is assessed through self-reporting and use of an accelerometer at baseline, 6 and 12 months
16. ADL and IADL are measured with a standardized questionnaire at baseline, 6 and 12 months
17. Emotional well-being is measured with the satisfaction with life scale, Diener 1989; Internationally reliable short form of the Positive and Negative Affect Schedule at baseline, 6 and 12 months, and personality is assessed with the Eysenck Personality Inventory, Floderus B. 1974, at baseline and 12 months and the NEO-Personality Inventory-3 (NEO-PI) at 12 months

Secondary ID(s)

Nil known

n:o 296843

Source(s) of Monetary Support

Suomen Akatemia

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; The Ethical Commettee of Central Finland Health care District, 14/12/2016, ref: 11/2016

Results

• Results available: Yes
• Date Completed: 31/03/2020