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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03162484
Other study ID # Universidad Politécnica
Secondary ID
Status Completed
Phase N/A
First received October 28, 2016
Last updated May 19, 2017
Start date September 2016
Est. completion date May 2017

Study information

Verified date May 2017
Source Universidad Politecnica de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. The consequences of an ABI may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their Health-Related Quality of Life (HRQoL).

The purpose of this project is to determine the effect of a physical activity group program on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice physical activity.


Description:

This study is a quasi experimental pre-post test with nonequivalent group design. There were two groups: 30 subjects with chronic ABI took part in a physical activity group program designed by a Sport Club in Madrid, Spain; and 30 subjects with chronic ABI which did not practice physical activity.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Individuals with mild to moderate chronic acquired brain injury from any cause.

- Being over 18 years of age.

- Being practice two or more sessions per week.

- Ability to understand and complete questionnaires in Spanish.

- Voluntary participation in the study.

- Signed informed consent by the patient and/or their primary caregiver.

Exclusion Criteria:

- Return to work

- Aphasia

Study Design


Intervention

Behavioral:
Experimental group
The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Politecnica de Madrid

Outcome

Type Measure Description Time frame Safety issue
Primary Mood change measurement Profile of Mood States (POMS) Questionnaire Change from baseline mood at 18 weeks
Primary Quality of life change measurement Short Form 36 Health Survey Change from baseline quality of life at 18 weeks
Primary Participation in Physical Activities change measurement Global Physical Activity Questionnaire Change from baseline participation at 18 weeks
Secondary Depression change measurement Beck Depression Inventory Change from baseline depression at 18 weeks
Secondary Months since injury sociodemographic data questionnaire Baseline
Secondary Amount of weekly physical activity sociodemographic data questionnaire Baseline
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