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

ISRCTN	ISRCTN00378146
DOI	https://doi.org/10.1186/ISRCTN00378146
Protocol serial number	16/2006
Sponsor	University of Extremadura (Spain)
Funder	Ministry of Work and Social Affairs (IMSERSO) (Spain) (ref: 118/06)

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

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

Primary study design	Interventional
Study design	Randomised controlled trial.
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	Validity and reliability of instruments (fitness tests that will be used in this sub-population for the first time) in poliomyelitis.
Completion date	20/12/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Study website	Study website	11/11/2025	11/11/2025	No	Yes