Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.
-
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.