Physical exercise
OtherPhysical exercise
NCT Number: NCT05131113
Multicenter randomized controlled trial. Patients will be randomly assigned to the control group or the intervention group in each of the health centers.
The control group will receive the usual care, while the intervention group will add an individualized physical exercise program to the usual care.
Cancer is a disease of the elderly. More than 65% of all malignancies affect this population. At the same time, the incidence of cancer cases increases and the need to better understand the biological characteristics of the disease, as well as those of the elderly who suffer from it, is highlighted.
Oncogeriatrics is the area that addresses the care of the elderly patient with cancer, taking into account that physiological aging causes older people to have their own characteristics that require a differential approach in care. The low inclusion in clinical trials of elderly patients and the few specific trials carried out in this subpopulation together with the progressive aging of the population mean that the development of this area has become a priority in health policies.
Therefore, there is a need to focus the research area on supervised physical exercise in older people with cancer in an innovative way, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction into the health system of this type of interventions.
Looking for future studies?
Notify Me70 year–100 year
All sexes
Interventional
Not applicable
Hospital Universitario Donostia, San Sebastián, Guipuzcoa, Spain
It seems useful to have instruments that help to objectively evaluate the fragilty and comorbidity of patients with the intention of adequately indicating the administration of antineoplastic treatment. In addition, nowadays, with the arrival of new less toxic treatments, it is essential to make a good selection of the patients to be treated, since there is a risk of treating patients who are not going to benefit from an active treatment just for having more comfortable medications and with less toxicity.
There are several instruments that can help to better select the patients that the investigators are going to treat and to select the supportive care that can help to better tolerate the proposed treatments while maintaining the best possible quality of life. Some of those instruments are aimed at detecting fragility such as comprehensive geriatric assessment. They identify in more detail the different vulnerabilities that can affect the patient in the benefit vs. toxicity balance of the treatment and in the long-term quality of life
Many authors emphasize the importance of including a physical exercise program during and after cancer treatment. Despite this, older people with cancer usually have low levels of physical activity, and few adhere to the recommendations they receive from health centers. For this reason, involving older people with cancer in a regular physical activity program becomes a challenge for those in charge of health centers.
Some studies have shown that physical exercise can reduce the usual loss of functional capacity and reduce frailty during cancer treatment. On the other hand, physical exercise can help reduce pain, toxicity and improve the completion rate of systemic treatment. Recent studies have found that physical exercise on the days of chemotherapy cycles is safe and may be beneficial in reducing neuropathy and maintaining physical well-being. Additionally, physical exercise can impact one of the most common and strenuous adverse effects of cancer treatment, fatigue.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical exercise
Time frame: 12 weeks
Short Physical Performance Battery (SPPB) evaluates balance, gait ability, and leg strength using a single tool. The score for each part is given in categorical modality (0-4). The best score will be 12 points. 1 point of change in the total score has demostrated to be of clinical relevance.
Time frame: 12 weeks
Abbreviated Gijón Scale (3-15 pts)
Time frame: 12 weeks
Barthel Index (0-100 pts)
Time frame: 12 weeks
Lawton´s test (0-8 pts)
Time frame: 12 weeks
Pfeiffer test (0-10 pts)
Time frame: 12 weeks
Yesavage test-short form (0-15 pts) (Yes/No)
Time frame: 12 weeks
MNA-SF test (0-14)
Time frame: 12 weeks
Number of chronic drugs consumed by the patient
Time frame: 12 weeks
Immobility and pressure ulcers (Yes/No); instability and falls (Yes/No); urinary and faecal incontinence (Yes/No); dementia and acute confusional syndrome ( Yes//No); malnutrition (Yes/No); alterations in sight and hearing (Yes/No);constipation, faecal impaction (Yes/No);depression/insomnia (Yes/No)
Time frame: 12 weeks
VAS (0-10 pts)
Time frame: 12 weeks
Stress thermometer (0-10 pts)
Time frame: 12 weeks
Time frame: 12 weeks
Unit of measure: kg
Time frame: 12 weeks
Unit of measure: cm
Time frame: 12 weeks
Unit of measure: cm
Time frame: 12 weeks
Time frame: 12 weeks
· Resistance (Ω)
Time frame: 12 weeks
· Phase angle (º)
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Biomarkers in the cell fraction of blood samples. Panel of 7 genes related to aging and frailty in RNA extracted from blood leukocytes, by quantitative PCR (qPCR): EGR1, Hsa-miR454, DDX11L1, G0S2, GJB6, CXCL8 and NSF. This panel has been developed at Biodonostia as a diagnostic and frailty stratification tool (European Patent Application EP3599286).
Time frame: 12 weeks
>Heart rate (bpm)
Time frame: 12 weeks
>Time spent cycling (min/sec)
Time frame: 12 weeks
> Maximum W
Time frame: 12 weeks
G8 scale ( 0-17); Fried Frailty Phenotype (0-5 pts)
Time frame: 12 weeks
8 Foot Up and Go Test (8FUGT) (sec)
Time frame: 12 weeks
Sleep efficiency (%)
Time frame: 12 weeks
Moderate too vigorous physical activity (min/d)
Time frame: 12 weeks
Sedentary time (h/d)
Time frame: 12 weeks
Light physical activity (min/d)
Time frame: 12 weeks
EORTC QLQ-FA12
Time frame: 12 weeks
EORTC QLQ-C30
Time frame: 12 weeks
Simplified Nutritional Appetite Questionnire
Time frame: 12 weeks
Cognitive Failures Questionnaire
Time frame: 12 weeks
Godin Physical Activity Questionnaire
Time frame: 12 weeks
Time frame: 12 weeks
Beliefs, barriers, facilitators and self-efficacy in relation to physical exercise ( self-developed questionnaire)
Time frame: 12 weeks
Self- developed questionnaire
Time frame: 12 weeks
Self- developed questionnaire
Time frame: 12 weeks
Self- developed questionnaire
Biogipuzkoa Health Research Institute
Other
Acronym: ONKO-FRAIL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07635901
Behavior, Effectiveness
Chennai, Tamil Nadu, India
View Trial DetailsNCT05378724
Activation, Patient, Behavior
Nijmegen, Gelderland, Netherlands
View Trial DetailsNCT03061370
Atrophy, Behavior
Dublin, Ireland
View Trial DetailsNCT03340857
Behavior, Cancer
Saint-Martin-d'Hères, Auvergne-Rhône-Alpes, France
View Trial Details