Cost-utility and efficacy of a home-based exercise program in poliomyelitis survivors

ISRCTN	ISRCTN00378146
DOI	https://doi.org/10.1186/ISRCTN00378146
Secondary identifying numbers	16/2006

Submission date: 07/08/2007
Registration date: 19/09/2007
Last edited: 30/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Narcis Gusi
Scientific

Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain

Phone	+34 9272 57460
Email	ngusi@unex.es

Study information

Study design	Randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Bioethical Committee of University of Extremadura, approved on 25 May 2006 (ref: 16/2006)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/08/2007
Completion date	20/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	40
Key inclusion criteria	Paralytic poliomyelitis survivors with one (or two) lower limb affected more than twenty years ago, recruited through local associations.
Key exclusion criteria	1. Medical contraindication to physical exercise 2. Doing regular physical exercise within 6 month before trial
Date of first enrolment	20/08/2007
Date of final enrolment	20/12/2007

Locations

Countries of recruitment

Spain

Study participating centre

Faculty of Sports Sciences

Caceres
10071
Spain

Sponsor information

University of Extremadura (Spain)
University/education

Fitness and Quality of Life Laboratory
Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain

Phone	+34 9272 57460
Email	ngusi@unex.es
Website	http://www.unex.es
"ROR"	https://ror.org/0174shg90

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan