Condition category
Musculoskeletal Diseases
Date applied
01/06/2006
Date assigned
13/07/2006
Last edited
06/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Contact information

Type

Scientific

Primary contact

Ms Erja Portegijs

ORCID ID

Contact details

Finnish Centre for Interdisciplinary Gerontology
Department of Health Sciences
University of Jyväskylä
P.O. Box 35 (viv)
Jyväskylä
FI-40014
Finland
erja.portegijs@sport.jyu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Older people with a history of hip fracture often have generally low muscle strength and power in the lower limbs, especially on the fractured side, which may result in mobility limitations. This considerable asymmetrical deficit may further complicate balance and independent living.

Progressive strength-power training may increase muscle strength and power. Taking into account asymmetrical deficit in the lower limbs may lead to larger improvements in mobility function in older people than conventional strength training.

Ethics approval

The study was approved by the Ethical Committee of the Jyväskylä Central Hospital Board on 14/10/2004

Study design

A randomised controlled trial; men and women randomised in blocks. Data collected in two phases using the exact same protocol equipment and staff.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hip fracture

Intervention

Participants assigned to the intervention groups, participated twice a week in a 12-week progressive strength-power training specifically designed to increase lower limb muscle strength and power and to reduce asymmetry in lower limb strength and power. Resistance equipment was used to train: leg press, knee flexion, hip abduction and adduction exercises, in addition, plantar flexion exercise was provided by means of a weighted vest. The one repetition maximum (1 RM; calculated from the observed 3-5 RM) for the exercises used in the training was assessed twice during the training. The resistance of the strength training (usual velocity) was progressively increased from 50 to 80 % of the 1RM of the respective leg. Leg press and plantar flexion exercises were trained in addition with high-velocity low-load resistance (power training). For these exercises, the number of repetitions was progressively increased. In order to equalise muscle strength and power asymmetry between the legs, the weaker leg was trained with more sets of repetitions and/or a higher percentage of resistance. The training was supervised by an experienced physiotherapist.

The participants assigned to the control group were encouraged to continue their lives as they were used to.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Maximal muscle strength and power in both legs:
1.1. Voluntary isometric knee extension strength
1.2. Rate of force production
1.3. Leg extension power (Nottingham power-rig)
2. The strength and power difference between the legs (asymmetry)
3. Mobility (habitual and maximal walking velocity and other walking parameters, such as step length and time
4. Time of walking a figure 8
5. Ability and time to climb stairs
6. Timed-up-go test
7. Chair rise ability and time

Secondary outcome measures

1. Balance:
1.1. Static and dynamic balance measured on a force plate
1.2. Functional balance (Berg balance scale)
1.3. Self-assessed balance confidence (ABC scale)
2. Falls (collected retrospectively and by means of a prospective follow-up)
3. Disability
4. Pain in the legs
5. Bone density and geometry of tibia (peripheral computed tomography)

Overall trial start date

01/06/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Community-dwelling 60 - 85-year-old men and women living in the Jyvaskyla Central Hospital District that had an operation following a hip fracture, from six months to seven years earlier

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

30 participants in each group (60 in total)

Participant exclusion criteria

The criteria of American College of Sports Medicine (e.g. severe cardiovascular disease) were used to exclude people from participation in the randomized controlled trial. Additionally, severe progressive (e.g. cancer) or neurological disease (e.g. advanced Alzheimer's disease), lower limb amputation, inability to walk outside without assistance of another person and alcohol abuse were used as exclusion criteria for this study.

Recruitment start date

01/06/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Finland

Trial participating centre

Finnish Centre for Interdisciplinary Gerontology
Jyväskylä
FI-40014
Finland

Sponsor information

Organisation

Ministry of Education Finland

Sponsor details

PL 29
00023 Valtioneuvosto
Helsinki
FI-00023
Finland
opmkirjaamo@minedu.fi

Sponsor type

Government

Website

http://www.minedu.fi

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

Finnish Cultural Foundation (Finland)

Alternative name(s)

Finnish Cultural Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

Funder name

Juho Vainio Foundation (Finland)

Alternative name(s)

Juho Vainio Foundation, Reppy Institute

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

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. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18760151
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22698990

Publication citations

  1. Results

    Portegijs E, Kallinen M, Rantanen T, Heinonen A, Sihvonen S, Alen M, Kiviranta I, Sipilä S, Effects of resistance training on lower-extremity impairments in older people with hip fracture., Arch Phys Med Rehabil, 2008, 89, 9, 1667-1674, doi: 10.1016/j.apmr.2008.01.026.

  2. 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.

Additional files

Editorial Notes