Clinical trial NCT06853613: Comparing Multicomponent and Aerobic Training: Impact on Fitness, Psychological and Quality of Life Parameters in Cancer Survivors Patients
Official title: Effects of an Adapted Multicomponent Training Program (Adapted Physical and Sports Activity - AFA) for Promoting Mental and Physical Well-being in Cancer Survivors Currently in Physiological or Chronic-stabilized Condition
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Keywords: cancer-related fatigue
mental and physical well-being
muscle function
anxiety-depressive symptoms
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body body fat percentage
timeFrame: 24-weeks
measure: Change in Body Water
timeFrame: 24-weeks
measure: Change in Muscle Mass
timeFrame: 24-weeks
measure: Change in lower body strength
timeFrame: 24-weeks
measure: Change in functional mobility
timeFrame: 24-weeks
measure: Change in Handrigp Strength
timeFrame: 24-weeks
measure: Change in aerobic capacity
timeFrame: 24-weeks
measure: Change in lower body flexibility
timeFrame: 24-weeks
measure: Change in upper body flexibility
timeFrame: 24-weeks
measure: Change in psychological parameters (anxiety).
timeFrame: 24-weeks
measure: Change in psychological parameters (depression).
timeFrame: 24-weeks
measure: Change in psychological parameters (Fatigue).
timeFrame: 24-weeks
measure: Change in psychological parameters (Quality of Life).
timeFrame: 24-weeks
measure: Change in psychological parameters (Coping).
timeFrame: 24-weeks
Secondary outcomes:
measure: Evaluation of adherence to training protocols
timeFrame: 24-weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Società Ginnastica Angiulli
Study officials:
affiliation: University of Bari Aldo Moro
name: Luca Poli, Dr.
role: PRINCIPAL_INVESTIGATOR
References: