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

NCT ID: NCT06853613

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-06-30

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.

Conditions

Cancer Survivors

Study Design

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

Study Groups

Multicomponent Training (MCT)

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

Group Type: EXPERIMENTAL

Multicomponent Training Protocol

Intervention Type: OTHER

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Aerobic training (AT)

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

Group Type: EXPERIMENTAL

Aerobic Training Protocol

Intervention Type: OTHER

Each training session will include an initial 10-minute muscle activation phase (low-intensity walking, Borg = 10-11) to increase heart rate, improve muscle blood flow, and prepare the major joints for the next work phase.

main exercise period (40-minute):

25 minutes of progressive aerobic exercises (controlled and rhythmic jumping jacks, step-ups on a sturdy platform (such as a low step or stable surface), standing knee raises (alternating legs), fast side steps or side leg raises).

15 minutes of walking, exercises will be performed at an intensity to ensure that perceived exertion (RPE) will remain between 13 and 15 points on the Borg Scale (6-20). Progression over the weeks will be by maintaining intensity in this range.

Cool down period: breathing and stretching exercises on all major muscle groups.

Waiting List Control Group (WLCG)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multicomponent Training Protocol

Each session consists of:

Warm-up (10 minutes): Low-intensity walking (Borg scale 10-11) to increase heart rate, improve blood flow, and prepare joints.

Main phase (40 minutes):

Aerobic exercises: Controlled jumping jacks, step-ups, alternating knee lifts, lateral steps, and leg lifts.

Mobility exercises: Thoracic extensions, cat-to-cows, overhead stretching with a stick, and hip internal rotations (1-3 sets, 30-60 seconds per exercise).

Resistance training: Gradual progression of 8 exercises targeting major muscle groups, such as squats, bicep curls, shoulder presses, and rows (1-3 sets, 10-15 reps, RPE 13-15).

Cool-down (10 minutes): Breathing exercises and stretching (1-3 sets, 10-30 seconds per stretch).

Intervention Type: OTHER

Aerobic Training Protocol

Each training session will include an initial 10-minute muscle activation phase (low-intensity walking, Borg = 10-11) to increase heart rate, improve muscle blood flow, and prepare the major joints for the next work phase.

main exercise period (40-minute):

25 minutes of progressive aerobic exercises (controlled and rhythmic jumping jacks, step-ups on a sturdy platform (such as a low step or stable surface), standing knee raises (alternating legs), fast side steps or side leg raises).

15 minutes of walking, exercises will be performed at an intensity to ensure that perceived exertion (RPE) will remain between 13 and 15 points on the Borg Scale (6-20). Progression over the weeks will be by maintaining intensity in this range.

Cool down period: breathing and stretching exercises on all major muscle groups.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari Aldo Moro

OTHER

Sponsor Role: lead

Responsible Party

Luca Poli

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Poli, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bari Aldo Moro

Locations

Società Ginnastica Angiulli

Bari, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

0324886

Identifier Type: -

Identifier Source: org_study_id