Condition category
Signs and Symptoms
Date applied
06/10/2005
Date assigned
15/11/2005
Last edited
12/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raija Leinonen

ORCID ID

Contact details

Finnish Centre for Interdisciplinary Gerontology
University of Jyväskylä
P.O. Box 35 (Viveca)
Jyväskylä
FIN-40014
Finland
+358 (0)14 260 2176
raija.leinonen@sport.jyu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ministry of Education: 104/22/2004; Ministry of Social Affairs and Health: 09/TER/2005

Study information

Scientific title

Acronym

SCAMOB

Study hypothesis

Physical activity counseling promotes physical activity, prevents mobility limitation and disability in older people.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Mobility limitation

Intervention

The intervention comprised a physical activity counseling session together with a physiotherapist followed by regular phone contacts four times a year throughout the two-year intervention. We promoted use of existing exercise services available for older people which are available for the participants also after finishing the project. The control group received no intervention. Physical activity, health and mobility were followed-up in three biannual telephone interviews in both the intervention and control group throughout the intervention. The follow-up interviews and physical assessments corresponding to those of baseline were done two years after the baseline in 2005. After these two-year follow-up examinations physical activity level and mobility limitation will be followed-up in three telephone interviews six months apart to the end of 2006. Follow-up of service use will continue until the end of the year 2007 and follow-up of institutionalisation and mortality until the death of the participant or 20 years; the data will be collected from population registers.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Physical activity level
2. Functional impairments
3. Mobility limitation
4. Disability
5. Quality of life

Secondary outcome measures

1. Use of health and social services
2. Institutionalisation
3. Mortality

Overall trial start date

31/03/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Cognitively intact community-living older people; the study group consisted of all the 75 - 81 year-old people living in the city center area in Jyväskylä, Finland. The inclusion criteria were set as follows:
1. The ability to walk at least 0.5 km without assistance
2. Only moderately physically active or sedentary
3. No memory impairment (Mini Mental State Examination [MMSE] greater than 21)
4. No medical contraindications for physical activity
5. Informed consent to participate

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Target population n = 1310, study group n = 632

Participant exclusion criteria

Those with severe mobility limitation (not able to walk 0.5 km independently), and those who were physically active (greater than 4 exercise a week), were excluded. In addition, subjects with MMSE points less than 22 were excluded.

Recruitment start date

31/03/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Finland

Trial participating centre

Finnish Centre for Interdisciplinary Gerontology
Jyväskylä
FIN-40014
Finland

Sponsor information

Organisation

Ministry of Education (Finland)

Sponsor details

PL 29
00023 Valtioneuvosto
Helsinki
00023
Finland

Sponsor type

Government

Website

http://www.minedu.fi/OPM/?lang=en

Funders

Funder type

Government

Funder name

Ministry of Education (Finland)

Alternative name(s)

Ministry of Education of the Republic of Korea, MOE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

Funder name

Ministry of Social Affairs and Health (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

City of Jyväskylä (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Jyväskylä (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17394477
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20881453
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21911336

Publication citations

  1. Protocol

    Leinonen R, Heikkinen E, Hirvensalo M, Lintunen T, Rasinaho M, Sakari-Rantala R, Kallinen M, Koski J, Möttönen S, Kannas S, Huovinen P, Rantanen T, Customer-oriented counseling for physical activity in older people: study protocol and selected baseline results of a randomized-controlled trial (ISRCTN 07330512)., Scand J Med Sci Sports, 2007, 17, 2, 156-164, doi: 10.1111/j.1600-0838.2006.00536.x.

  2. Results

    Sallinen J, Mänty M, Leinonen R, Kallinen M, Törmäkangas T, Heikkinen E, Rantanen T, Factors associated with maximal walking speed among older community-living adults., Aging Clin Exp Res, 2011, 23, 4, 273-278, doi: 10.3275/7270.

  3. Results

    Rasinaho M, Hirvensalo M, Törmäkangas T, Leinonen R, Lintunen T, Rantanen T, Effect of physical activity counseling on physical activity of older people in Finland (ISRCTN 07330512)., Health Promot Int, 2012, 27, 4, 463-474, doi: 10.1093/heapro/dar057.

Additional files

Editorial Notes