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11 February 2012
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| [ Print-friendly version ] |
| Mobility recovery after hip fracture: physical activity and rehabilitation program among community-dwelling hip fracture patients |
| ISRCTN | ISRCTN53680197 |
| ClinicalTrials.gov identifier | |
| Public title | Mobility recovery after hip fracture: physical activity and rehabilitation program among community-dwelling hip fracture patients |
| Scientific title | Physical activity and rehabilitation program among community-dwelling hip fracture patients: a single centre randomised controlled trial |
| Acronym | ProMo |
| Serial number at source | N/A |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Finland |
| Disease/condition/study domain | Collum or pertrochanter fracture |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 30/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 42 per group (total: 84) |
| Interventions |
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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding |
1. Ministry of Education (Finland)
2. The Social Insurance Institution of Finland (Kela) (Finland) |
| Trial website | https://www.jyu.fi/sport/laitokset/tutkimusyksikot/sgt/en |
| Publications | |
| Contact name | Dr Sarianna Sipilä |
| Address | Rautpohjank 8a |
| City/town | Jyvaskyla |
| Zip/Postcode | 40700 |
| Country | Finland |
| sarianna.sipila@jyu.fi | |
| Sponsor | Ministry of Education (Finland) |
| Address |
PL 29
Valtioneuvosto |
| City/town | Helsinki |
| Zip/Postcode | 00023 |
| Country | Finland |
| Sponsor website: | http://www.minedu.fi/OPM/?lang=en |
| Date applied | 24/09/2009 |
| Last edited | 03/03/2010 |
| Date ISRCTN assigned | 03/03/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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