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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.

Primary Purpose

Cancer, Cancer-Related Syndrome, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multimodal Exercise and Functional Rehabilitation Program
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Rehabilitation, Occupational therapy, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Having among the reasons for admission a pathological diagnosis of newly diagnosed or relapsed oncological disease.
  • Being admitted to the Oncology Service of the Salamanca University Hospital.
  • Barthel index score between 15 and 55 points.
  • Level of tumor asthenia greater than or equal to 4 on the EVA scale for tumor asthenia.
  • Sign an informed consent in which they authorize their voluntary participation in the study (Annex II).

Exclusion criteria:

  • Present cognitive impairment assessed with the Mini-mental State Examination (MMSE) less than 24 points.
  • Present hemoglobin levels below 10g / dl.

Withdrawal criteria:

  • Exitus of the patient.
  • Progression of the disease leading to a terminal state.
  • Hospitalization of the patient at the time of home monitoring.
  • Do not carry out Final Assessment.

Sites / Locations

  • Universidad de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group. Health education program

Experimental Group. Multimodal Exercise and Functional Rehabilitation Program

Arm Description

The participants in this group will undergo the usual clinical practice: compliance and adherence to the prescribed drug treatment will be explained, as well as the established guidelines for individualized health care. A Health Education Program will also be added at discharge, mainly aimed at reinforcing and promoting an active and healthy life.

Prescription of multimodal physical exercise. A supervised and structured home program will be carried out for one month. It will be carried out daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. Each session will be structured in a warm-up, a main part and a cool-down and relaxation (14). Reeducation of Activities of Daily Living (ADL). Specific training will be carried out after the evaluation and before the discharge of the patients from the university healthcare complex. It is intended to identify the factors that are interfering with the performance of activities of daily living. The intervention will consist of three parts: Direct intervention on Activities of Daily Living (ADL), carried out in situ in the hospitalization and generalizable to their daily environment; teaching in Energy Saving Techniques (APR). Prescription of support products and adaptations of the environment.

Outcomes

Primary Outcome Measures

Activities of Daily Living (ADL)
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

Cancer related fatigue
Functional evaluation of cancer therapy- Anemia" FACT-An "in its 4th version and the VAS scale.
Attention and executive functions
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)
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
Visual Analogue Scale (VAS) will be used. Minimum score 0, maximum score 10. Higher scores indicate worse status.
Functional Capacity
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
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
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
Meters

Full Information

First Posted
February 16, 2021
Last Updated
July 12, 2022
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT04761289
Brief Title
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.
Official Title
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. Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cancer-Related Syndrome, Fatigue
Keywords
Cancer, Rehabilitation, Occupational therapy, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group. Health education program
Arm Type
Active Comparator
Arm Description
The participants in this group will undergo the usual clinical practice: compliance and adherence to the prescribed drug treatment will be explained, as well as the established guidelines for individualized health care. A Health Education Program will also be added at discharge, mainly aimed at reinforcing and promoting an active and healthy life.
Arm Title
Experimental Group. Multimodal Exercise and Functional Rehabilitation Program
Arm Type
Experimental
Arm Description
Prescription of multimodal physical exercise. A supervised and structured home program will be carried out for one month. It will be carried out daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. Each session will be structured in a warm-up, a main part and a cool-down and relaxation (14). Reeducation of Activities of Daily Living (ADL). Specific training will be carried out after the evaluation and before the discharge of the patients from the university healthcare complex. It is intended to identify the factors that are interfering with the performance of activities of daily living. The intervention will consist of three parts: Direct intervention on Activities of Daily Living (ADL), carried out in situ in the hospitalization and generalizable to their daily environment; teaching in Energy Saving Techniques (APR). Prescription of support products and adaptations of the environment.
Intervention Type
Other
Intervention Name(s)
Multimodal Exercise and Functional Rehabilitation Program
Intervention Description
Prescription of multimodal physical exercise. Reeducation of Activities of Daily Living (ADL). Prescription of support products and adaptations of the environment.
Primary Outcome Measure Information:
Title
Activities of Daily Living (ADL)
Description
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).
Time Frame
BASAL VISIT: It will be carried out at the time prior to the discharge of hospitalization patients.
Secondary Outcome Measure Information:
Title
Cancer related fatigue
Description
Functional evaluation of cancer therapy- Anemia" FACT-An "in its 4th version and the VAS scale.
Time Frame
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.
Title
Attention and executive functions
Description
The Trail Making Test (TMT) will be used. The TMT is used to assess attention, flexibility of thought and visuospatial ability.
Time Frame
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.
Title
Health-related quality of life (HRQL)
Description
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.
Time Frame
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.
Title
Cancer pain
Description
Visual Analogue Scale (VAS) will be used. Minimum score 0, maximum score 10. Higher scores indicate worse status.
Time Frame
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.
Title
Functional Capacity
Description
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
Time Frame
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.
Title
Kinesiophobia
Description
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.
Time Frame
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.
Title
Weight
Description
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.
Time Frame
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.
Title
Height
Description
Meters
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Having among the reasons for admission a pathological diagnosis of newly diagnosed or relapsed oncological disease. Being admitted to the Oncology Service of the Salamanca University Hospital. Barthel index score between 15 and 55 points. Level of tumor asthenia greater than or equal to 4 on the EVA scale for tumor asthenia. Sign an informed consent in which they authorize their voluntary participation in the study (Annex II). Exclusion criteria: Present cognitive impairment assessed with the Mini-mental State Examination (MMSE) less than 24 points. Present hemoglobin levels below 10g / dl. Withdrawal criteria: Exitus of the patient. Progression of the disease leading to a terminal state. Hospitalization of the patient at the time of home monitoring. Do not carry out Final Assessment.
Facility Information:
Facility Name
Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34686180
Citation
Fernandez-Rodriguez EJ, Gonzalez-Sanchez J, Puente-Gonzalez AS, Recio-Rodriguez JI, Sanchez-Gomez C, Mendez-Sanchez R, Cruz-Hernandez JJ, Rihuete-Galve MI. Multimodal physical exercise and functional rehabilitation program in oncological patients with asthenia. study protocol. BMC Nurs. 2021 Oct 22;20(1):207. doi: 10.1186/s12912-021-00734-9.
Results Reference
derived

Learn more about this trial

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.

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