Comparing Multicomponent and Aerobic Training: Impact on Fitness, Psychological and Quality of Life Parameters in Cancer Survivors Patients

University of Bari Aldo Moro

Status: Completed

Conditions: Cancer Survivors

Treatments: Other: Multicomponent Training Protocol; Other: Aerobic Training Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06853613

0324886

Details and patient eligibility

About

The goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an aerobic training program (AT) can improve physiological, physical fitness, mental well-being, and quality of life in cancer survivors currently stabilized. The main questions it aims to answer are:

Does MCT or AT improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does MCT provide superior physiological an psychological improvements compared to AT?

Researchers will compare:

MCT (a combination of aerobic, mobility, and resistance training exercises) AT (an aerobic-solo training) to see if these interventions improve fitness, health, psychological and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant differences between MCT and AT .

Participants will:

Complete assessments of anthropometric, physical fitness, and psychological parameters at baseline (T0) and after 24 weeks (T1).

Be randomly assigned to one of three groups (MCT, AT, or WLCG).

Engage in a 24-week structured training program (MCT or IMCT) supervised by exercise professionals, including:

Warm-up sessions (10 minutes, low-intensity walking). Main sessions (40 minutes): aerobic, mobility, resistance (MCT), only-aerobic (AT) exercises.

Cool-down sessions (10 minutes): breathing and stretching exercises.

This study will provide insights into the efficacy of tailored physical activity interventions for stabilized Cancer survivors.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women/Men;
• Age between 18 and 80 years at the time of initial treatment;
• Subjects in remission for at least 3 months;
• No diagnosis of secondary cancer at baseline;
• No physical impediment to physical activity (Eastern Cooperative Oncology Groups (ECOG) performance status 0-1);
• Signature of a written informed consent form (or their legally recognized representatives must sign) indicating that the patient understood the purpose and procedures required for the study and is willing to participate in the study;
• Sedentary lifestyle (subjects who have not followed WHO guidelines for aerobic and resistance exercise in the past 3 months).
• Currently in treatment, as long as not hospitalized, in stabilized chronic condition,
• Positive medical specialist assessment of noncompetitive physical activity practice.

Exclusion criteria

• Metastasis;
• Uncontrolled hypertension or untreated heart disease;
• Severe musculoskeletal or joint disorders with severe mobility limitations;
• Psychiatric disorders;
• Taking psychotropic drugs;
• Inability to engage in physical activity;
• Lack of fitness to practice sports.
• Expected absence of more than two weeks during the intervention period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Multicomponent Training (MCT)

Experimental group

Description:

subjects assigned to the MCT group will perform a training protocol defined multicomponent training, which includes aerobic, resistance and flexibility components.

Treatment:

Other: Multicomponent Training Protocol

Aerobic training (AT)

Experimental group

Description:

subjects assigned to the AT group will perform training protocol of only aerobic exercises.

Treatment:

Other: Aerobic Training Protocol

Waiting List Control Group (WLCG)

No Intervention group

Description:

Subjects assigned to the WLCG group will not engage in any structured physical activity throughout the intervention period, continuing with their usual lifestyle, and will be placed on a waiting list, ensuring their participation in adapted physical activity at the end of the 24-week intervention.