NCT04761289

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.

Completed NA Last updated 15 July 2022

What this trial tests

NA trial testing Multimodal Exercise and Functional Rehabilitation Program in Cancer in 50 participants. Completed in 31 December 2021.

Timeline

1 May 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	University of Salamanca
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	1 May 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Spain

Drugs / interventions tested

• Multimodal Exercise and Functional Rehabilitation Program

Conditions studied

• Cancer — all drugs for Cancer →
• Cancer-Related Syndrome — all drugs for Cancer-Related Syndrome →
• Fatigue — all drugs for Fatigue →

Sponsor

University of Salamanca

Who can join

18 and older, any sex, with Cancer or Cancer-Related Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multimodal physical exercise and functional rehabilitation program in oncological patients with asthenia. study protocol.
   Fernández-Rodríguez EJ, González-Sánchez J, Puente-González AS, Recio-Rodríguez JI, et al · · 2021 · cited 1× · PMID 34686180 · DOI 10.1186/s12912-021-00734-9
2. Multimodal physical exercise and functional rehabilitation program in oncological patients with cancer-related fatigue. A randomized clinical trial
   Rodriguez EJF, Gomez CS, Hernandez JJC, Rodriguez JIR, et al · · 2022 · DOI 10.21203/rs.3.rs-2085699/v1