Condition category
Musculoskeletal Diseases
Date applied
01/07/2013
Date assigned
16/07/2013
Last edited
16/07/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Joint hypermobility (some or all of a person's joints have an unusually large range of movement) is often seen in rheumatologic patients (patients suffering from a painful disorder affecting the joints, muscles, tissues around the joints, and bones) and it often remains unclear how disabling the joint hypermobility is for a person. Generally women are more often affected and the hypermobility usually decreases with age. Currently there is not clear which treatment is best. This study aims to explore the effect of a 12-week strength training program on the pain and disability of women with joint hypermobility.

Who can participate?
The study will involve women aged between 20 and 40 years with generalized joint hypermobility who are interested in doing a 12-week strength training program in a medical fitness centre.

What does the study involve?
Participants in the study are randomly allocated to one of the two groups: one group will immediately start with a strength training program, the other will not change lifestyle habits for 12 weeks. The changes in muscle strength, performance in daily life and disability between these two groups will be compared. After the 12 weeks of waiting the second group will also do the training and then for all participants the effects in the long term (three months after training until one year) are compared to the condition at the beginning of the study.
The strength training will involve exercises for thigh and calf muscles, as well as for the back and the abdomen, all performed on fitness machines. The training will be guided by an experienced physiotherapist. Two training sessions each week of about 50 min should be performed during the 12 weeks. In week 1, 3 and 6 an individual instruction session will take place, while the other sessions are performed under general supervision.
To assess the effects, several measurements will take place before the training, after the training or waiting period (12 weeks) and three months after the end of the training. The measurements will test the strength of the knee extension and knee flexion muscles. Stair climbing as daily-life activity and the passive mobility of the knee are also measured. To detect changes in the muscles, the bone and muscle properties of the thigh and lower leg will be measured by means of quantitative computer tomography (pQCT).
For measuring the effects on pain and disability in daily life three questionnaires will be used, which are filled in by the participants. At all measurement points the questionnaires will also be filled in, as well as six and 12 months after the end of the training.

What are the possible benefits and risks of participating?
The benefit for the participant is a guided and supervised 12-week strength training program free of charge. The training and the functional measurements do not involve any more risk for injury or pain than normal daily life or sports activities. The measurements with the pQCT lead to a low radiation dose, comparable to 5% of the dose during a transatlantic flight. The total time for the training will be about 24 hours and for the assessments 10-12 hours per participant.

Where is the study run from?
Bern University Hospital - Department of Physiotherapy, in Collaboration with the Department of Rheumatology, Clinical Immunology and Allergology of the Bern University Hospital, Switzerland.

When is the study starting and how long is it expected to run for?
The study is planned to start in August 2013 and the end of recruitment is estimated to be in Summer 2014. The last follow-up will take place in October 2015. The recruitment is planned for one year or until 50 participants are involved in the study.

Who is funding the study?
The Bern University Hospital, Department of Physiotherapy

Who is the main contact?
Gere Luder, PT, MSc
gere.luder@insel.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Aeberli

ORCID ID

Contact details

Department of Rheumatology
Clinical Immunology and Allergology
Bern University Hospital
PKT2 U1 576
Bern
CH-3010
Switzerland
daniel.aeberli@insel.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Insel-Nr: 2303

Study information

Scientific title

Joint hypermobility: effect of a strength training program on disability and function: a randomised controlled trial

Acronym

Study hypothesis

Primary aim is to look at immediate effects of a specific strength training program on muscle strength, functional movements, pain and disability in daily-life of hypermobile women, compared to a control group.
Secondary aims are:
1. To evaluate the feasibility of this strength training program for hypermobile women
2. To look at the long-term effects of the training intervention, especially the influence of the strength training on pain and disability in daily-life.
Based on the above mentioned questions the following hypotheses are tested by this project:
Primary Hypothesis:
Hprim: A specific 12 week strength training leads to an increase of muscle mass and muscle strength in women with generalised joint hypermobility.
Additional hypotheses:
H1, feasibility: A specific 12 week strength training can be completed by women with generalised joint hypermobility without severe side effects or an increase of pain and disability.
H2, quality of life: A specific 12 week strength training leads to an improved quality of life in women with generalised joint hypermobility, due to less disability and pain in daily-life activities.
H3, mid-term physiological changes: The improvement in muscle mass and muscle strength in women with generalised joint hypermobility due to a specific 12 week strength training is holding on three months after the end of the training.
H4, mid-term quality of life: The improvement in quality of life in women with generalised joint hypermobility due to a specific 12 week strength training is holding on three months after the end of the training.
H5, long-term quality of life: The improvement in quality of life in women with generalised joint hypermobility due to a specific 12 week strength training is holding on six months after the end of the training.
H6, long-term quality of life: The improvement in quality of life in women with generalised joint hypermobility due to a specific 12 week strength training is holding on one year after the end of the training.

Ethics approval

Ethical approval was obtained from the Ethics Committee of Canton Bern, Switzerland on 07/02/2013 with the study number 222/12

Study design

Single-centre single-blinded randomised controlled trial with waiting list design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Joint Hypermobility

Intervention

Strength training for 12 weeks with two training sessions of about 50- 60 minutes weekly in a medical training fitness, totally 24 training sessions.

First two weeks: complex method, two series with 25 repetitions at a resistance of 40-50% of the one repetition maximum (1RM).

Second phase (week 3 to 12): hypertrophy training, three series with 12 repetitions at 80% of 1RM. The Training is instructed and supervised by an experienced physiotherapist.

Exercises: 10 min warm-up on cycle ergometer or stepper, leg-press, knee flexion and knee extension in open chain, hip abductors, triceps surae on the leg press (heel-rise), back extension and abdominals.

Comparator: 12 weeks without changing lifestyle habits

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Primary outcome for the effect of strength training is the increase in muscle strength, measured as maximum isometric strength and the rate of force development (RFD) of knee extensors and knee flexors on a custom-built strength measurement table with a force transducer. Measured at baseline, after training respectively waiting period (12 weeks) and three months after end of the training.

Secondary outcome measures

1. Ground reaction forces (GRF) and muscle activity (EMG) during stair ascent and descent: GRF measured with force plates on a custom-built six step standard stair at self-selected speed. EMG of following leg muscles with surface electrodes: vastus lateralis, vastus medialis, biceps femoris and semitendinosus.
2. Passive tibial translation: passive ventral displacement of the tibia against the femur in the ventral direction, measured with an adapted Aircast Rolimeter.
3. Peripheral quantitative computer tomography (pQCT): Muscle and bone variables measured at thigh and lower leg, as well as distal radius: Bone density of tibia, femur and radius, muscle cross-sectional area at thigh, calf and forearm.
4. Three questionnaires for pain and disability, as well as general health: 1. Medical Outcomes Study Short Form 36-Item (SF-36). 2. Arthritis Impact Measurement Scales 2 (AIMS-2). 3. Self-developed questionnaire for pain and disability in functional activities using 5 point likert-scales.
GRF and EMG during stair climbing, tibial translation and pQCT will be measured at baseline, after training respectively waiting period (12 weeks) and three months after end of the training. The questionnaires will be filled in at all these time points and additionally six and twelve months after end of the training.

Overall trial start date

01/08/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with generalized joint hypermobility
2. 20 to 40 years old
3. Normal body mass index (BMI) (between 18-30 kg/m2)
4. At least 6/9 points in the Beighton score
5. Right knee extension beyond 10°
6. Able to understand German questionnaires

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

Participant exclusion criteria

1. Surgery of the legs or lumbar spine in the last two years
2. Doing more than four hours per week of regular intense sports
3. Pregnancy or less than one year after delivery
4. Known genetic diseases of connective tissue like Marfan syndrome and Osteogenesis imperfecta, as well as Ehler-Dahnlos-syndrome I and II

Recruitment start date

01/08/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Switzerland

Trial participating centre

Department of Rheumatology, Clinical Immunology and Allergology
Bern
CH-3010
Switzerland

Sponsor information

Organisation

Bern University Hospital (Switzerland)

Sponsor details

c/o Martin Verra (Head of the department)
Department of Physiotherapy
PKT2 U1 551
Bern
CH-3010
Switzerland
martin.verra@insel.ch

Sponsor type

Hospital/treatment centre

Website

http://www.insel.ch

Funders

Funder type

Hospital/treatment centre

Funder name

Bern University Hospital - Department of Physiotherapy (Switzerland)

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

Publication citations

Additional files

Editorial Notes