Condition category
Infections and Infestations
Date applied
07/08/2007
Date assigned
19/09/2007
Last edited
30/08/2011
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://afycav.es/index.php?lang=en

Contact information

Type

Scientific

Primary contact

Prof Narcis Gusi

ORCID ID

Contact details

Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain
+34 9272 57460
ngusi@unex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16/2006

Study information

Scientific title

Acronym

Study hypothesis

1. A home-based exercise program is effective in improving health-related quality of life, neuromuscular function and fitness in paralytic poliomyelitis survivors
2. A home-based exercise program is cost-effective compared to usual care in paralytic poliomyelitis survivors

Ethics approval

Bioethical Committee of University of Extremadura, approved on 25 May 2006 (ref: 16/2006)

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Poliomyelitis

Intervention

Participants will be randomised to the experimental and control groups (usual care). The experimental group of participants will be asked to perform 3 months of home-based physical exercises including two one-hour sessions per week. They will be instructed by a sport sciences graduate to perform progressive (set of 10 to 30 repetitions) strength-resistance exercises (flexion and extension of trunk and limbs; abduction and adduction of shoulder).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be measured at 0 (before start), 3 (end of exercise period) and 6 months (detraining in intervention group):
1. Health related quality of life (the EQ-5D questionnaire, 15-D instrument and the 36-item Short Form health survey [SF-36])
2. Sanitary costs (consultations, medication, health utilities, cost of program)
3. Back disorders (Roland Morris Scale)
4. Fatigue scale (FSS)
5. Neuromuscular function - isokinetic dynamometry: moment of force and power (root mean square electromyogram [EMGrms])
6. Fitness (strength, flexibility, balance, 6 min walk test, body composition)

Secondary outcome measures

Validity and reliability of instruments (fitness tests that will be used in this sub-population for the first time) in poliomyelitis.

Overall trial start date

20/08/2007

Overall trial end date

20/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Paralytic poliomyelitis survivors with one (or two) lower limb affected more than twenty years ago, recruited through local associations.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Medical contraindication to physical exercise
2. Doing regular physical exercise within 6 month before trial

Recruitment start date

20/08/2007

Recruitment end date

20/12/2007

Locations

Countries of recruitment

Spain

Trial participating centre

Faculty of Sports Sciences
Caceres
10071
Spain

Sponsor information

Organisation

University of Extremadura (Spain)

Sponsor details

Fitness and Quality of Life Laboratory
Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain
+34 9272 57460
ngusi@unex.es

Sponsor type

University/education

Website

http://www.unex.es

Funders

Funder type

Government

Funder name

Ministry of Work and Social Affairs (IMSERSO) (Spain) (ref: 118/06)

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