Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/09/2009
Date assigned
03/03/2010
Last edited
11/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.jyu.fi/sport/laitokset/tutkimusyksikot/sgt/en

Contact information

Type

Scientific

Primary contact

Dr Sarianna Sipilä

ORCID ID

Contact details

Rautpohjank 8a
Jyvaskyla
40700
Finland
-
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 measures

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

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

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

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes

11/05/2016: Internal review.