Effects of a Multimodal Physical Exercise and Functional Rehabilitation Program on Fatigue, Pain, Functional Capacity and Quality of Life in Cancer Patients With Tumor Asthenia.
- Conditions
- CancerCancer-Related SyndromeFatigue
- Registration Number
- NCT04761289
- Lead Sponsor
- University of Salamanca
- Brief Summary
Tumor asthenia is the most common symptom associated with cancer and its treatment. Although the estimated prevalence varies between 60-90%, and it is considered the longest-lasting symptom in cancer patients, having the greatest impact on quality of life parameters, it is a problem that is still undervalued in general by health professionals . It has been observed that individuals with this process find it difficult to normalize their daily life, either due to a deterioration in their clinical condition or due to a problem in the generalization of what they have learned during their hospital stay. That is why we plan to carry out a clinical trial, to evaluate the effect of a controlled patient follow-up program, and thus be able to address these difficulties in the most optimal way. A randomized clinical trial of two parallel groups will be carried out, belonging to the oncology service of the University Hospital of Salamanca. 44 participants with tumor asthenia, who are admitted at the time of inclusion, will be selected through a consecutive sampling. After the baseline evaluation, the participants will be randomized into two groups. The subjects of the experimental group will carry out a Functional Rehabilitation Program, with a duration of one month. The main variable will be the evaluation of the basic activities of daily life (Barthel scale). The secondary variables will be oriented to evaluate the change in tumor asthenia, attention and cognitive functions, parameters of quality of life, pain, functional capacity and body composition. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with tumor asthenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Activities of Daily Living (ADL) BASAL VISIT: It will be carried out at the time prior to the discharge of hospitalization patients. Barthel index (BI) will be used, whose version has been translated and validated into Spanish (4). The scale assigns a score based on their degree of dependency to perform a series of basic activities, obtaining a score on each item that ranges from 0 to 15 points. The global range can vary between 0 (completely dependent) and 100 points (completely independent).
- Secondary Outcome Measures
Name Time Method Cancer related fatigue FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. Functional evaluation of cancer therapy- Anemia" FACT-An "in its 4th version and the VAS scale.
Attention and executive functions FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. The Trail Making Test (TMT) will be used. The TMT is used to assess attention, flexibility of thought and visuospatial ability.
Health-related quality of life (HRQL) FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. It will be evaluated using the EuroQol 5-D questionnaire (EQ-5D). An adapted version of this will be used questionnaire, which has been validated in the Spanish population. Minimum score 5, maximum score 15. Higher scores indicate worse status.Minimum score 5, maximum score 15. Higher scores indicate worse status.
Cancer pain FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. Visual Analogue Scale (VAS) will be used. Minimum score 0, maximum score 10. Higher scores indicate worse status.
Functional Capacity FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. The short physical performance battery (SPPB), validated in our setting for primary health care, is a test specifically designed to predict disabilities (10) and has demonstrated the ability to predict adverse events, dependence, institutionalization and mortality
Kinesiophobia FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. The Tampa Scale for Kinesiophobia (TSK), is a measurement scale developed to evaluate fear of movement related to pain, mainly in patients with musculoskeletal pain. The modified scale of 11 will be applied items (TSK-F), validated version in cancer patients. Minimum score 11, maximum score 44. Higher scores indicate worse status.
Weight FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. Kilograms obtaining data on fat mass, fat-free mass, musculoskeletal mass, total body water and body fat percentage. The device used will be the Tanita BC 418 MA (Tanita Corporation, Japan) (13). Height will be measured using a portable system (Seca 222), calculating the average of two measurements registered.
Height FOLLOW-UP VISITS 15 DAYS AND 1 MONTH: These visits will be identical to the baseline evaluation except for the collection of sociodemographic variables, which will only be carried out in the baseline evaluation. Meters
Trial Locations
- Locations (1)
Universidad de Salamanca
🇪🇸Salamanca, Spain
Universidad de Salamanca🇪🇸Salamanca, Spain