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.

July 12, 2022 updated by: Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37001
        • Universidad de Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group. Health education program
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.
Other: Multimodal Exercise and Functional Rehabilitation Program
  1. Prescription of multimodal physical exercise.
  2. Reeducation of Activities of Daily Living (ADL).
  3. Prescription of support products and adaptations of the environment.
Experimental: Experimental Group. Multimodal Exercise and Functional Rehabilitation Program
  1. 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).
  2. 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).
  3. Prescription of support products and adaptations of the environment.
Other: Multimodal Exercise and Functional Rehabilitation Program
  1. Prescription of multimodal physical exercise.
  2. Reeducation of Activities of Daily Living (ADL).
  3. Prescription of support products and adaptations of the environment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Activities of Daily Living (ADL)
Time Frame: 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).
BASAL VISIT: It will be carried out at the time prior to the discharge of hospitalization patients.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cancer related fatigue
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.
Functional evaluation of cancer therapy- Anemia" FACT-An "in its 4th version and the VAS scale.
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.
Attention and executive functions
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.
The Trail Making Test (TMT) will be used. The TMT is used to assess attention, flexibility of thought and visuospatial ability.
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.
Health-related quality of life (HRQL)
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.
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.
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.
Cancer pain
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.
Visual Analogue Scale (VAS) will be used. Minimum score 0, maximum score 10. Higher scores indicate worse status.
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 Capacity
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.
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
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.
Kinesiophobia
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.
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.
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.
Weight
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.
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.
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.
Height
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.
Meters
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 245381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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