Plain English Summary
Background and study aims
Falls are one of the leading causes of death and injury in people over the age of 65. Studies have shown that getting more exercise can help to lower the risk of falls by improving balance, coordination and strength. Many older people find it difficult to get enough exercise, and so actively encouraging and promoting regular participation in physical activity (PA) is especially important. Being able to safely move around outside the home is important part of long-term independence in old age. There are a range of services and activities available in the community to promote health and well-being, however many older people are unable to access these. It has been found that the many older people tend to stay in areas they know well. Life-space mobility is a way of measuring the size of the area that a person has moved around in over the last month (i.e. home, yard, neighbourhood, town and beyond town). Many people feel that if they go beyond this “comfort zone” then they are more likely to have a fall and injure themselves, greatly limiting their independence. In order to try to help people with a limited area of mobility, health kiosks have been set up in public places. A health kiosk is a place which is easily accessible locally, that can provide easily accessible healthcare. The aim of this study is to find out whether offering individual counselling sessions to older people at a health kiosk is an effective and cost-effective way of encouraging older people to become more active.
Who can participate?
Adults aged 65 or over with a history of falls and mobility issues.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in 5 hour-long individual counselling sessions. During these sessions participants are taught about strengthening their leg muscles, balance, walking, stair climbing, and active range of movement exercises, as well as a referral to a community specialised gym. The participants are also given advice about safety issues and the importance of a healthy lifestyle. Those in the second group are given placebo (dummy) exercises involving relaxation and mindfulness (being aware of yourself and everything around you), as well as written material about the importance of exercise.
What are the possible benefits and risks of participating?
Participants may experience benefits to their health such as lowering the risk of developing health problems such as heart disease and diabetes. Physical activity could also help them to do more day-to-day and reduce their risk of falls in the long-run. Risks of participating are small however when people increase their level of physical activity, there is a risk of sore muscles and falls.
Where is the study run from?
The Ylöjärvi Health Kiosk (Finland)
When is the study starting and how long is it expected to run for?
September 2015 to December 2018
Who is funding the study?
Academy of Finland (Finland)
Who is the main contact?
1. Dr Johanna Edgren (Public)
johanna.edgren@jyu.fi
2. Dr Riku Nikander (Scientific)
riku.p.nikander@jyu.fi
Trial website
Contact information
Type
Public
Primary contact
Dr Johanna Edgren
ORCID ID
http://orcid.org/0000-0003-1839-9737
Contact details
University of Tampere
Faculty of Social Sciences
Department of Health Sciences
Arvo Ylpön katu 34
P.O. Box 100
Tampere
33014
Finland
+358 40 8053869
johanna.edgren@jyu.fi
Type
Scientific
Additional contact
Dr Riku Nikander
ORCID ID
Contact details
University of Jyväskylä
Faculty of Sport and Health Sciences
Gerontology Research Center
Keskussairaalantie 4
P.O. Box 35
Jyväskylä
40100
Finland
+358 40 8054818
riku.p.nikander@jyu.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Physical activity counselling and exercise program targeting for increased physical activity, life-space mobility and falls prevention among community-dwelling older people: A single-center randomized controlled trial
Acronym
COSMOS
Study hypothesis
1. The Health Kiosk environment incorporating targeted counselling and referral to an evidence-based exercise program will improve physical and muscle performance and mobility, decrease falls and fall-related injuries and improve overall PA levels and health-related quality of life
2. The Health Kiosk environment will represent a cost-effective model for preventing falls and will increase the number of participants capable of independent living post intervention and two years after the end of the 24-month intervention
Ethics approval
The Regional Ethics Committee of the Expert Responsibility area of Tampere University Hospital, 03/11/2015, ref: R15160
Study design
Single-centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Falls
Intervention
Participants are randomly allocated to one of two groups:
Current interventions as of 04/05/2018:
Control group: Participants will receive a placebo intervention including five face to face sessions of mindfulness relaxation exercises. Exercise program will be up dated during each face to face session and each exercise is provided on CD.
Intervention group: There will be five Health Kiosk-based 1.5-hour sessions including a 30-minute counselling session for motivation together with a 1-hour exercise education session. Exercise education contains strengthening exercises for lower extremity muscles. The program also includes balance, walking and stair climbing exercises and active range of movement exercises (for example, neck rotations and hip and knee extensions). During the sessions the exercise referral to the local community specialized gym will be also given. The participants will receive a progressive written exercise program with schematic drawings. In addition, 11 supportive telephone calls will be provided. The safety issues of physical activity, counselling to reduce alcohol consumption and smoking, recommendation to use anti-slippery shoe devices will be advised.
The total duration of the intervention is 24 months. Both groups are followed up 24 months after the intervention.
Previous interventions as of 30/08/2016:
Control group: Participants will receive a placebo intervention including five face to face sessions of mindfulness relaxation exercises. Exercise program will be up dated during each face to face session and each exercise is provided on CD.
Intervention group: There will be five Health Kiosk-based 1-hour sessions including a 20-minute counselling session for motivation together with a 40-minute exercise education session. Exercise education contains strengthening exercises for lower extremity muscles. The program also includes balance, walking and stair climbing exercises and active range of movement exercises (for example, neck rotations and hip and knee extensions). During the sessions the exercise referral to the local community specialized gym will be also given. The participants will receive a progressive written exercise program with schematic drawings. In addition, 11 supportive telephone calls will be provided. The safety issues of physical activity, counselling to reduce alcohol consumption and smoking, recommendation to use anti-slippery shoe devices will be advised.
The total duration of the intervention is 24 months. Both groups are followed up 24 months after the intervention.
Original text:
Control group: Participants will receive a placebo intervention including one-time group session of mindfulness relaxation exercises and a written exercise program.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Life-space mobility assessed by a validated questionnaire (Life-spece mobility measures mobility based on distance through which a person reports moving during the 4 weeks preceding the assessment. Questions establish movement to specific life-space levels ranging from within one’s dwelling to beyond one’s town) at baseline, 12, 24 and 48 months
2. Number of falls and fall-related injuries: monthly collected fall-diaries will be used to collect information on falls and fall-related injuries and registers will be used to verify severe injuries at baseline, 12, 24 and 48 months
Secondary outcome measures
Current secondary outcome measures as of 04/05/2018:
1. Physical activity is assessed using a Finnish Hookie AM 20 triaxial accelerometer for 7 days and physical activity diary for 4 weeks at baseline, 12, 24 and 48 months
2. Physical performance is measured using the Timed Up and Go-test (TUG) , Short Physical Performance Battery (SPPB) and Jamar hand dynamometer at baseline, 12, 24 and 48 months
3. Quality of life is measured using The World Health Organization Quality of Life (WHOQOL) questionnaire at baseline, 12, 24 and 48 months
4. Living-arrangements are determined by asking patients at baseline, 12, 24 and 48 months
5. Number of fallers based on monthly collected fall-diaries at baseline, 12, 24 and 48 months
6. Fracture risk is assessed using the WHO Fracture Risk Assessment Tool at baseline, 12, 24 and 48 months
7. Mental status is assessed using the Geriatric Depression Scale (GDS-15) at baseline, 12, 24 and 48 months
8. Cognitive status is assessed using the Mini-Mental State Examination (MMSE) at baseline, 12, 24 and 48 months
9. Balance confidence as a measure of fear of falling is assessed using the Activities-specific Balance Confidence scale (ABC) at baseline, 12, 24 and 48 months
Previous secondary outcome measures:
1. Physical activity is assessed using a Finnish Hookie AM 20 triaxial accelerometer for 7 days and physical activity diary for 4 weeks at baseline, 12, 24 and 48 months
2. Physical performance is measured using the Timed Up and Go-test (TUG) , Short Physical Performance Battery (SPPB) and Jamar hand dynamometer at baseline, 12, 24 and 48 months
3. Quality of life is measured using The World Health Organization Quality of Life (WHOQOL) questionnaire at baseline, 12, 24 and 48 months
4. Living-arrangements are determined by asking patients at baseline, 12, 24 and 48 months
5. Falls rate is measured using a short risk profile interview (i.e. “Have you fallen (and if so, how many times) during the previous year (without substantial external force)?) at baseline, 12, 24 and 48 months
6. Fracture risk is assessed using the WHO Fracture Risk Assessment Tool at baseline, 12, 24 and 48 months
7. Mental status is assessed using the Geriatric Depression Scale (GDS-15) at baseline, 12, 24 and 48 months
8. Cognitive status is assessed using the Mini-Mental State Examination (MMSE) at baseline, 12, 24 and 48 months
Overall trial start date
01/09/2015
Overall trial end date
30/06/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 65 years or over
2. Community-living people
3. Living in Ylöjärvi, Finland, or neighbouring municipalities
4. At least minor mobility difficulty
Removed 30/08/2016:
4. History of fall(s)
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
450 (225+225)
Participant exclusion criteria
1. Severe functional limitations (unable to walk 500 m unaided)
2. Severe cardiovascular or pulmonary disease
3. Severe progressive disease
4. Terminally ill (predicted lifetime <12 months)
5. Memory impairment (MMSE score 21 points or less)
6. Living in an institution
7. Unwilling to be randomized
Added 30/08/2016:
8. Alcoholism (AUDIT score ≥ 15)
Recruitment start date
01/01/2016
Recruitment end date
31/03/2019
Locations
Countries of recruitment
Finland
Trial participating centre
The Ylöjärvi Health Kiosk
Elotie 1
Ylöjärvi
33470
Finland
Sponsor information
Organisation
University of Jyväskylä
Sponsor details
Department of Health Sciences
Seminaarinkatu 15
PL 35
Jyväskylä
40014
Finland
+358 14 2601211
firstname.lastname@jyu.fi
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Academy of Finland (Suomen Akatemia)
Alternative name(s)
Suomen Akatemia, Finlands Akademi
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Finland
Results and Publications
Publication and dissemination plan
The research results will be published in high-class scientific journals such as Journal of the American Medical Association (JAMA), British Medical Journal (BMJ) or Journal of the American Geriatrics Society. In 2017, we will report the results from the baseline data and results from the follow up data in 2019.
As of 04/05/2018, the researchers intended to publish the study protocol by 31/01/2019.
IPD sharing statement:
The datasets generated during and/or analyzed during the current study will be available upon request from Dr Riku Nikander, riku.p.nikander@jyu.fi
The datasets generated during and/or analyzed during the current study will also be stored in a publically available repository: Dataverse platform (https://dvn.jyu.fi/dvn/).
Data will be available from 5/2019 until 2029 (at least 10 years from the end of data collection) for research and/or education purposes for research collaborators as soon as the data will be collected and if the primary research group who has collected the data do not intend to utilize the requested data. Data will be available for secondary (ancillary) analyses. The primary research group will accomplish analyses of RCT design. Data will be provided only anonymized based on the Finnish legislation of personal data and statement given by the Regional Ethics Committee of the Expert Responsibility area of Tampere University Hospital. An informed consent has been obtained from participants when enrolled on the study.
Intention to publish date
30/06/2019
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list