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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02350582
Other study ID # SAS-0457-2010
Secondary ID
Status Completed
Phase N/A
First received January 26, 2015
Last updated July 21, 2017
Start date April 2012
Est. completion date August 2016

Study information

Verified date July 2017
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with breast cancer undergo a series of psiclofisicas alterations during cancer treatment, chemotherapy phase being one of the more aggressive ete effect. These changes reduce the quality of life and result in a loss of physical health-related condition. Studies have shown that the practice of physical exercise and rehabilitation strategies enhance or attenuate the impact of chemotherapy on quality of life of patients. At present, technological development from telerehabilitación systems is a promising strategy that enables fast and efficient communication between health professionals and patients, especially at this stage of the disease where the patient may encounter difficulties in matching measures improving their lifestyle with aggressive medical treatment.

To carry out this study a controlled study masked, parallel-group done were conducted usual care control group and an intervention based on a web system telerehabilitación to improve the physical condition associated with health and performed quality of life.


Description:

The CUIDATE group will identify impairments of participants at baseline assessment. The aims based on weekly improvements will be set to facilitate the final goal. After each training session there will be feedback between the participant and the CUIDATE group to change or improve any exercise or activity. This feedback will allow to us to select adequate exercises and levels of difficulty. As a result, a modifiable personal training will be assigned to each one focusing on cardio-respiratory, mobility, and endurance performance through online system rehabilitation (using written instructions, HD videos, and audio files).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis of stage I, II, or IIIA breast cancer

- Medical clearance of participation

- Access to the Internet

- Basic ability to use a computer or living with someone who has this ability

- In chemotherapy treatment at present moment;

- Have interest in improving lifestyle: fitness level

- Have signed informed consent

Exclusion Criteria:

- Chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program;

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Telerehabilitation eCUIDATE system
Resistence and endurance exercise adapted to individual requeriment during chemotherapy

Locations

Country Name City State
Spain Faculty of Health Sciences. University of Granada Granada

Sponsors (2)

Lead Sponsor Collaborator
Universidad de Granada Health Service of Andalucia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory capacity Distance in meters in 6 minutes walking test 1 day
Secondary Abdominal endurance strength Abdominal resistance using curl-up test 1 day
Secondary Lumbar extensor endurance strength Lumbar extensor strength using dynamometer 1 day
Secondary Handgrip endurance strength Handgrip endurance using isometric dynamometer 1 day
Secondary Cancer related fatigue Piper Fatigue Scale 2 days
Secondary Cancer related pain Brief Pain Inventory 2 days
Secondary Cancer related quality of life EORTC Quality of life questionaire Core and Br23 2 days
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