Mobility recovery after hip fracture: physical activity and rehabilitation program among community-dwelling hip fracture patients

ISRCTN	ISRCTN53680197
DOI	https://doi.org/10.1186/ISRCTN53680197
Secondary identifying numbers	N/A

Submission date: 24/09/2009
Registration date: 03/03/2010
Last edited: 11/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Sarianna Sipilä
Scientific

Rautpohjank 8a
Jyvaskyla
40700
Finland

Email	sarianna.sipila@jyu.fi

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Physical activity and rehabilitation program among community-dwelling hip fracture patients: a single centre randomised controlled trial
Study acronym	ProMo
Study objectives	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(s)	Ethical Committee of the Jyväskylä Central Hospital Board approved on the 18th August 2007 and 22nd August 2008.
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2008
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	42 per group (total: 84)
Total final enrolment	81
Key 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
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Finland

Study participating centre

Rautpohjank 8a

Jyvaskyla
40700
Finland

Sponsor information

Ministry of Education (Finland)
Government

PL 29
Valtioneuvosto
Helsinki
00023
Finland

Website	http://www.minedu.fi/OPM/?lang=en
"ROR"	https://ror.org/02w52zt87

Funders

Funder type

Government

Ministry of Education (Finland)

No information available

The Social Insurance Institution of Finland (Kela) (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No
Results article	results	01/12/2013		Yes	No
Results article	results	01/05/2014		Yes	No
Results article	results	01/04/2015		Yes	No
Results article	results	09/06/2020	11/06/2020	Yes	No

Editorial Notes

11/06/2020: Publication reference and total final enrolment number added.
11/05/2016: Internal review.