Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sarianna Sipilä
ORCID ID
Contact details
Rautpohjank 8a
Jyvaskyla
40700
Finland
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sarianna.sipila@jyu.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Physical activity and rehabilitation program among community-dwelling hip fracture patients: a single centre randomised controlled trial
Acronym
ProMo
Study hypothesis
This study investigates the effects of a rehabilitation program on mobility and functional capacity of older community-dwelling people operated for hip fracture.
Ethics approval
Ethical Committee of the Jyväskylä Central Hospital Board approved on the 18th August 2007 and 22nd August 2008.
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Collum or pertrochanter fracture
Intervention
Intervention group:
Individually tailored physical rehabilitation program aiming to restore mobility (ProMo). The purpose of the intervention is to restore mobility after hip fracture. The one year intervention starts within one month (at least six weeks after discharged from the health care centre. ProMo is a multicomponent rehabilitation protocol consisting of individual progressive home exercise program and counselling/management sessions for physical activity promotion and pain and fear of falling management. Usage and satisfaction with assistive devices for walking will also be discussed.
Control group:
Usual care. The control group is instructed to follow the guidelines provided by the hospital and healt care centre.
The total duration of the intervention is 12 months. The subjects (both intervention and control groups) will be followed up for 12 months after the intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The short term primary outcome (at 3 and 6 months) is Short Physical Performance Battery (SPPB) including habitual walking speed, chair rise and balance tests. One year primary outcome will be mobility limitation and disability.
Secondary outcome measures
Measured at baseline, 3, 6 and 12 months:
1. Maximal and habitual walking speed over 10 metres
2. Isometric muscle strength for knee extension and leg extension power, assessed from both sides
3. Functional balance, assessed by Berg Balance Scale
4. Fear of falling, assessed by Activities-specific Balance Confidence scale
5. Pain, assessed by Visual Analogue Scale (VAS) and questionnaire
6. Functional capacity, assessed by validated questionnaire
7. Level of physical activity, assessed by a questionnaire
8. Information concerning use of formal and informal care
9. Bone density and geometry measured for lower leg
10. Depressive mood (Beck Depression Inventory [BDI])
Measured at baseline, 6 and 12 months:
11. Bone density and geometry measured for arm
Measured at baseline, 3, 6 and 12 months and 24 months (12 month follow-up):
12. Form of dwelling, collected by a questionnaire and health and social service registers
Overall trial start date
01/01/2008
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Over 60-year-old community-dwelling men and women operated for hip fracture at the local hospital during 2008 - 2009 and living in the city of Jyväskylä or neighbouring municipalities
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
42 per group (total: 84)
Participant exclusion criteria
1. Living in an institution
2. Confined to bed at the time of the fracture
3. Severe memory problems (min-mental state examination [MMSE] less than 19)
4. Severe cardiovascular or pulmonary disease
5. Severe progressive disease (i.e., neoplasm, amyotrophic lateral sclerosis [ALS])
6. Unwillingness to participate
Recruitment start date
01/01/2008
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Finland
Trial participating centre
Rautpohjank 8a
Jyvaskyla
40700
Finland
Sponsor information
Organisation
Ministry of Education (Finland)
Sponsor details
PL 29
Valtioneuvosto
Helsinki
00023
Finland
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Education (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Social Insurance Institution of Finland (Kela) (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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22698990
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23986910
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24559642
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25687927
Publication citations
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Results
Portegijs E, Edgren J, Salpakoski A, Kallinen M, Rantanen T, Alen M, Kiviranta I, Sihvonen S, Sipilä S, Balance confidence was associated with mobility and balance performance in older people with fall-related hip fracture: a cross-sectional study., Arch Phys Med Rehabil, 2012, 93, 12, 2340-2346, doi: 10.1016/j.apmr.2012.05.022.
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Results
Portegijs E, Rantakokko M, Edgren J, Salpakoski A, Heinonen A, Arkela M, Kallinen M, Rantanen T, Sipilä S, Effects of a rehabilitation program on perceived environmental barriers in older patients recovering from hip fracture: a randomized controlled trial., Biomed Res Int, 2013, 2013, 769645, doi: 10.1155/2013/769645.
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Results
Salpakoski A, Törmäkangas T, Edgren J, Kallinen M, Sihvonen SE, Pesola M, Vanhatalo J, Arkela M, Rantanen T, Sipilä S, Effects of a multicomponent home-based physical rehabilitation program on mobility recovery after hip fracture: a randomized controlled trial., J Am Med Dir Assoc, 2014, 15, 5, 361-368, doi: 10.1016/j.jamda.2013.12.083.
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Results
Edgren J, Salpakoski A, Sihvonen SE, Portegijs E, Kallinen M, Arkela M, Jäntti P, Vanhatalo J, Pekkonen M, Rantanen T, Heinonen A, Sipilä S, Effects of a Home-Based Physical Rehabilitation Program on Physical Disability After Hip Fracture: A Randomized Controlled Trial, J Am Med Dir Assoc, 2015, doi: 10.1016/j.jamda.2014.12.015.