Effects of a Specific Programme for the Recovery of Autonomy Plus Multimodal Physical Exercise in Oncology Patients With Dyspnoea

NCT ID: NCT04766593

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-12-31

Brief 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. 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.

Conditions

Cancer; Dyspnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oncological functional reeducation program

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.

Group Type: EXPERIMENTAL

Oncological functional reeducation program

Intervention Type: OTHER

It will consist of the following actions:

1. Prescription of multimodal physical exercise.

2. Retraining in activities of daily living.

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 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).

Group Type: ACTIVE_COMPARATOR

Oncological functional reeducation program

Intervention Type: OTHER

It will consist of the following actions:

1. Prescription of multimodal physical exercise.

2. Retraining in activities of daily living.

Interventions

Oncological functional reeducation program

It will consist of the following actions:

1. Prescription of multimodal physical exercise.

2. Retraining in activities of daily living.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Eduardo J Fernández Rodríguez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Salamanca

Salamanca, , Spain

Countries

Spain

Central Contacts

Eduardo IP Fernández, PhD

Role: CONTACT

edujfr@usal.es

699244390

Facility Contacts

Eduardo IP Fernández, PhD

Role: primary

edujfr@usal.es

699244390

References

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.

Reference Type: DERIVED

PMID: 34225735 (View on PubMed)

Other Identifiers

PI 2020 07 547

Identifier Type: -

Identifier Source: org_study_id