CancerNCT04766593
Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise in Oncology Patients With Dyspnoea
A study testing Oncological functional reeducation program in people with Cancer and Dyspnea, run by University of Salamanca at 1 site in Spain.
Trial summary
In recent years the survival of cancer patients has increased exponentially. But together with that survival, and due to the different oncological treatments, side effects have also increased significantly. Some of these may be tumor asthenia or dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Oncological functional reeducation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion criteria: pathological diagnosis of oncological disease, being admitted at the time of recruitment in the Oncology Unit of CAUSA, presenting dyspnea parameters equal to or greater than "2" points on the Medical Research Council (MRC) scale, a scoring less than 85 points on the Barthel index and having signed an informed consent that indicates the voluntary agreement to participate in the study.
- Exclusion criteria: not having an adequate cognitive state to understand and carry out the orders that are provided (scores lower than 23 points in Mini Mental State Examination, MMSE), present hemoglobin levels lower than 10g / dl, be an active smoker at the time of recruitment.
- Withdrawal criteria: progression of the disease that leads the patient to a terminal situation or death and failure to carry out the follow-up and final evaluation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Salamanca
Salamanca, 37001
Eduardo IP Fernández, PhD, 699244390, edujfr@usal.es
About this study
Official title: Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise on Functionality, Physical Performance, and Respiratory Parameters in Oncology Patients With Dyspnoea
In recent years the survival of cancer patients has increased exponentially. But together with that survival, and due to the different oncological treatments, side effects have also increased significantly. Some of these may be tumor asthenia or dyspnea. The latter can represent a serious health problem, with important limitations for individuals. To control this, we consider that the measures used in conventional clinical practice can be implemented, mainly developed through physical exercise. But we believe that not only this is enough, but we also propose an intervention with a comprehensive perspective from the rehabilitative approach, with the aim of integrating education and training of the oncological patient with dyspnea. We propose to combine the intervention with physical exercise with a re-education in the performance of activities of daily living, within a "Functional Oncological Re-education Program", to see if in this way better results are achieved in clinical practice.
That is why we propose to verify the effects produced by the implementation of a multimodal physical exercise program with a specific autonomy recovery program in comparison with an isolated intervention through physical exercise on the functionality and physical performance in cancer patients with dyspnea . To do this, we proposed an experimental, prospective, randomized study using a parallel scheme of fixed assignment with an experimental group and a control group in patients from the Oncology Hospitalization Unit of the Salamanca University Hospital Complex. 44 participants with dyspnea, who were 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 Rehabilitation Program in addition to the physical exercise carried out in all the participants. The main variable will be the performance of basic activities of daily living (Barthel scale) and the degree of dyspnea (mMRC scale). In addition, physical performance (SPPB), blood oxygen saturation (pulse oximetry), fear / avoidance of movement / TAMPA scale) and quality of life in cancer patients (ECOG) will be assessed. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with dyspnea.
- Being tested
- Oncological functional reeducation program
- Keywords
- Cancer, Rehabilitation, Occupational therapy, Dyspnea, Physical exercise
- Medical subject headings
- Neoplasms, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncological functional reeducation programOther
It will consist of the following actions:
- Prescription of multimodal physical exercise.
- Retraining in activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Oncological functional reeducation program | Experimental | It will consist of the following actions:
1. Prescription of multimodal physical exercise: This therapeutic measure will be carried out both in the individuals of the experimental group and in those of the control group. It will be held daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. The sessions were structured according to the recommendations of the American College of Sports Medicine (ACSM) 18, with an initial warm-up (2-3 minutes), a main part (8-12 minutes) and a final cool-down and relaxation (5 minutes).
2. Retraining in activities of daily living: Gradation and simplification of activities and training in energy saving techniques (EAT).
Finally, an exhaustive daily record of the activity carried out by the patient will be carried out, from which it will be modified, adapting it to the clinical situation of the patient. Receives: Other: Oncological functional reeducation program |
| Prescription of multimodal physical exercise | Active comparator | This therapeutic measure will be carried out both in the individuals of the experimental group and in those of the control group. It will be held daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. The guideline will be to maintain a multimodal exercise to perform exercises of different characteristics, including aerobic exercises, balance exercises and low-load strength exercises for muscle groups, both in the upper quadrant and the lower quadrant. The sessions were structured according to the recommendations of the American College of Sports Medicine (ACSM) 18, with an initial warm-up (2-3 minutes), a main part (8-12 minutes) and a final cool-down and relaxation (5 minutes). Receives: Other: Oncological functional reeducation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependency level
Barthel Index: Measure of physical disability with proven validity and reliability, easy to apply and interpret. Useful to assess functional disability in basic activities of daily living (ABVD). It establishes scores from 0 to 100 in which it quantifies the degree of dependence of the individual.
Measured: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Level of dyspnea
Medical Research Council de Disnea (mMRC): Its objective is to allow the patient to quantitatively grade their own dyspnea visually and easily. Establishes 5 degrees of dyspnea involvement in activities.
Measured: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Secondary outcomes (4)
Physical performance
Short Physical Performance Score (SPPB): The short physical performance battery, validated in our setting for primary health care, is a test specifically designed to predict disabilities and has demonstrated the ability to predict adverse events, dependency, institutionalization, and mortality.
Measured: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
kinesiophobia
Tampa Scale for Fatigue Associated Kinesiophobia (TSK-F): scale developed to assess fear of movement related to fatigue / pain, having been validated in cancer patients and chronic fatigue syndrome. The 11-item model (TSK-F-11) will be applied.
Measured: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Performance status
ECOG scale: it is a practical way to measure the quality of life of an oncology patient, whose life expectancy changes over the course of months, weeks and even days. It was designed by the Eastern Cooperative Oncology Group (ECOG) in the United States and validated by the World Health Organization (WHO). The main function of this scale is to objectify the quality of life of the patient or "performance status".
Measured: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Blood oxygen saturation
Pulse oximetry: non-invasive technique that measures the oxygen saturation (Sat O2) of hemoglobin in circulating blood, usually arterial blood, carried out using a pulse oximeter.
Measured: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766593
- Sponsor's protocol ID
- PI 2020 07 547
- Status last verified
- Apr 2021
- First submitted
- 16 Feb 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-Rodriguez EJ, Gonzalez-Sanchez J, Puente-Gonzalez AS, Recio-Rodriguez JI, Sanchez-Gomez C, Mendez-Sanchez R, Cruz-Hernandez JJ, Rihuete-Galve MI. Specific autonomy recovery programme in a comprehensive rehabilitation on functionality and respiratory parameters in oncological patients with dyspnoea. Study protocol. BMC Nurs. 2021 Jul 5;20(1):120. doi: 10.1186/s12912-021-00633-z.
PubMed 34225735
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise on Functionality, Physical Performance, and Respiratory Parameters in Oncology Patients With Dyspnoea
- ClinicalTrials.gov ID
- NCT04766593
- Acronym / sponsor ID
- PI 2020 07 547
- Keywords
- Cancer, Rehabilitation, Occupational therapy, Dyspnea, Physical exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent years the survival of cancer patients has increased exponentially. But together with that survival, and due to the different oncological treatments, side effects have also increased significantly. Some of these may be tumor asthenia or dyspnea. The latter can represent a serious health problem, with important limitations for individuals. To control this, we consider that the measures used in conventional clinical practice can be implemented, mainly developed through physical exercise. But we believe that not only this is enough, but we also propose an intervention with a comprehensive perspective from the rehabilitative approach, with the aim of integrating education and training of the oncological patient with dyspnea. We propose to combine the intervention with physical exercise with a re-education in the performance of activities of daily living, within a "Functional Oncological Re-education Program", to see if in this way better results are achieved in clinical practice.
That is why we propose to verify the effects produced by the implementation of a multimodal physical exercise program with a specific autonomy recovery program in comparison with an isolated intervention through physical exercise on the functionality and physical performance in cancer patients with dyspnea . To do this, we proposed an experimental, prospective, randomized study using a parallel scheme of fixed assignment with an experimental group and a control group in patients from the Oncology Hospitalization Unit of the Salamanca University Hospital Complex. 44 participants with dyspnea, who were 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 Rehabilitation Program in addition to the physical exercise carried out in all the participants. The main variable will be the performance of basic activities of daily living (Barthel scale) and the degree of dyspnea (mMRC scale). In addition, physical performance (SPPB), blood oxygen saturation (pulse oximetry), fear / avoidance of movement / TAMPA scale) and quality of life in cancer patients (ECOG) will be assessed. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with dyspnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncological functional reeducation program | Experimental | Other: Oncological functional reeducation programIt will consist of the following actions: 1. Prescription of multimodal physical exercise: This therapeutic measure will be carried out both in the individuals of the experimental group and in those of the control group. It will be held daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. The sessions were structured according to the recommendations of the American College of Sports Medicine (ACSM) 18, with an initial warm-up (2-3 minutes), a main part (8-12 minutes) and a final cool-down and relaxation (5 minutes). 2. Retraining in activities of daily living: Gradation and simplification of activities and training in energy saving techniques (EAT). Finally, an exhaustive daily record of the activity carried out by the patient will be carried out, from which it will be modified, adapting it to the clinical situation of the patient. |
| Prescription of multimodal physical exercise | Active comparator | Other: Oncological functional reeducation programThis therapeutic measure will be carried out both in the individuals of the experimental group and in those of the control group. It will be held daily in two short sessions of 15-20 minutes, one in the morning and one in the afternoon. The guideline will be to maintain a multimodal exercise to perform exercises of different characteristics, including aerobic exercises, balance exercises and low-load strength exercises for muscle groups, both in the upper quadrant and the lower quadrant. The sessions were structured according to the recommendations of the American College of Sports Medicine (ACSM) 18, with an initial warm-up (2-3 minutes), a main part (8-12 minutes) and a final cool-down and relaxation (5 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncological functional reeducation programIt will consist of the following actions: 1. Prescription of multimodal physical exercise. 2. Retraining in activities of daily living. | Other | Oncological functional reeducation program, Prescription of multimodal physical exercise |
Primary outcome
Dependency level
Time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Barthel Index: Measure of physical disability with proven validity and reliability, easy to apply and interpret. Useful to assess functional disability in basic activities of daily living (ABVD). It establishes scores from 0 to 100 in which it quantifies the degree of dependence of the individual.
Level of dyspnea
Time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Medical Research Council de Disnea (mMRC): Its objective is to allow the patient to quantitatively grade their own dyspnea visually and easily. Establishes 5 degrees of dyspnea involvement in activities.
4 secondary outcomes
Physical performance
Time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
kinesiophobia
Time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Performance status
Time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Blood oxygen saturation
Time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Derived from this study: PubMed 34225735Fernandez-Rodriguez EJ, Gonzalez-Sanchez J, Puente-Gonzalez AS, Recio-Rodriguez JI, Sanchez-Gomez C, Mendez-Sanchez R, Cruz-Hernandez JJ, Rihuete-Galve MI. Specific autonomy recovery programme in a comprehensive rehabilitation on functionality and respiratory parameters in oncological patients with dyspnoea. Study protocol. BMC Nurs. 2021 Jul 5;20(1):120. doi: 10.1186/s12912-021-00633-z.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncological functional reeducation program in people with Cancer and Dyspnea, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo IP Fernández, PhD (699244390, edujfr@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependency level (time frame: From the moment of admission to the hospital, until the moment of discharge, an average of 15 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.