Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer (PREDU)

March 24, 2026 updated by: Meritxell Parareda, University of Vic - Central University of Catalonia

Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer: Randomized Clinical Trial.

This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer.

The study hypothesis is that participation in this exercise program improves tolerance to chemotherapy, allowing patients to receive more than 85% of the planned relative dose intensity. In addition, the program is expected to enhance treatment effectiveness by increasing the rate of complete radiological response.

The main objective of the study is to assess the effectiveness of a supervised, multimodal therapeutic exercise program performed before and during chemotherapy in improving both treatment tolerance and treatment efficacy in patients with breast, lung, and colon cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study proposes a randomized, stratified, assessor-blinded, longitudinal, prospective clinical trial designed in accordance with the CONSORT guidelines.

This study is justified by the need to identify effective strategies to improve chemotherapy tolerance and efficacy, as well as to reduce adverse effects and preserve patients' quality of life. The available scientific evidence suggests that multimodal physical activity programs combining cardiovascular and strength training, particularly when supervised, individualized, initiated before treatment, and maintained throughout chemotherapy, may exert a positive impact on chemotherapy tolerance and efficacy. These variables are key determinants in achieving favorable indicators and in improving the side effects caused by chemotherapy.

OBJECTIVES AND HYPOTHESIS The primary objective is to evaluate the effectiveness of a supervised multimodal therapeutic exercise program, initiated before and maintained during chemotherapy, on treatment tolerance and efficacy in patients aged 35 to 65 years diagnosed with breast, lung, or colorectal cancer.

The following outcomes will be compared between the experimental and control groups:

  • Relative Dose Intensity (RDI)
  • Treatment completion rate
  • Radiological or pathological complete response

Secondary objectives include comparing the evolution of cancer-related fatigue, quality of life, muscular strength, cardiorespiratory capacity, and adherence to physical activity between both groups. Additionally, the study will explore whether tumor location, cancer stage, and age moderate the effect of the intervention on treatment tolerance and efficacy, as well as on secondary outcomes.

The main hypothesis is that participants performing supervised therapeutic exercise will more frequently achieve an RDI ≥85% compared to the control group and will demonstrate improved therapeutic efficacy outcomes.

STUDY DESIGN

Two parallel groups will be included:

Experimental Group (EG): supervised therapeutic exercise program Control Group (CG): unsupervised home-based physical activity with general recommendations

Randomization will be stratified according to cancer location (breast, lung, or colorectal) to ensure balance between groups. Allocation will be generated using computer software. Outcome assessors will be blinded to group assignment.

INTERVENTION

The total duration of the program will be 48 weeks, including 18 weeks of active intervention during chemotherapy and 24 weeks of follow-up after treatment completion.

CONTROL GROUP

Participants in the control group will receive standardized verbal and written recommendations to perform therapeutic physical activity at home in accordance with World Health Organization guidelines.

Recommendations will include:

3-4 weekly sessions of aerobic exercise (30-45 minutes at approximately 70% of maximum heart rate), such as walking, brisk walking, cycling, swimming, or rowing.

2 weekly strength-training sessions (approximately 30 minutes), including upper limb, trunk, and lower limb exercises at intensities between 50-80% of one-repetition maximum (1RM), consisting of 2 sets of 8-12 repetitions, using body weight and elastic resistance bands.

Low-intensity joint mobility exercises. These activities will not be supervised or individualized by the research team.

EXPERIMENTAL GROUP

Participants in the experimental group will perform supervised and individualized therapeutic exercise sessions in specialized centers. The program will be adapted according to fatigue levels and the phase of the chemotherapy cycle.

Three supervised sessions per week will be conducted:

One session focused on aerobic exercise (45 minutes), combining moderate continuous training (approximately 70% of maximum heart rate) with moderate interval training (>85% of maximum heart rate alternating with 50% of maximum heart rate), including Low-Intensity High-Intensity Interval Training (Low HIIT).

Two combined sessions (50 minutes each), including:

30 minutes of aerobic exercise 20 minutes of strength training at intensities between 50-80% of 1RM, 2 sets of 8-12 repetitions, using guided machines, elastic resistance bands, and free weights.

Exercises will target the main muscle groups (quadriceps, hamstrings, gluteal muscles, pectoralis major, latissimus dorsi, biceps, triceps, and lumbar musculature). All sessions will include low-intensity joint mobility exercises.

PROCEDURE AND ASSESSMENTS

Four assessment time points will be conducted:

Baseline (at diagnosis) At the start of chemotherapy At completion of chemotherapy At 24 weeks after completion of the intervention

The general areas assessed will include:

Relative Dose Intensity (RDI) Radiological complete response (RRC) Dynamic and static muscular strength Cardiorespiratory capacity Cancer-related fatigue Quality of life Adherence to physical activity

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Vic, Barcelona, Spain, 08500
        • Consorci Hospitalari de Vic
        • Contact:
          • Phone Number: (+34) 93 889 11 11
      • Vic, Barcelona, Spain, 08500
        • Facultat de Ciències de la Salut i del Benestar de la Universitat de Vic (UVIC-UCC) Universitat de Vic- Universitat Central de Catalunya
        • Contact:
      • Vic, Barcelona, Spain, 08500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women and men aged 35 to 65 years
  • Diagnosed with stage II, III, or IV breast, lung, or colon cancer
  • Scheduled to start neoadjuvant chemotherapy
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Musculoskeletal or neurological disorders that prevent proper execution of the exercises
  • Uncontrolled infections or symptoms
  • Comorbidities such as chronic obstructive pulmonary disease (COPD), respiratory failure, or recent cardiovascular events within the past 6 months
  • Body mass index (BMI) over 35
  • Pregnant women
  • Difficulty understanding the purpose and procedures of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
An exercise program based on guidance provided during the informational session and the provided brochure is followed, without planning, adaptation, or supervision. Recommendations include aerobic and strength training exercises.
Other: Recommendation Exercise Program
Participants follow unsupervised exercise recommendations during the 2 weeks before and the 16 weeks of chemotherapy. Aerobic exercises are 30-45 minutes, 3-4 times per week (walking, swimming, cycling), and strength exercises are 2 sessions per week, 30 minutes each, targeting upper limbs, trunk, and lower limbs. Participants are responsible for following these recommendations on their own, without individualized adaptation or supervision, aiming to meet WHO exercise guidelines for oncology populations.
Experimental: Experimental group
A supervised, planned, and adapted therapeutic physical exercise program is implemented according to fatigue levels and the phase of the neoadjuvant chemotherapy cycle. The program includes three supervised sessions per week combining aerobic and strength training exercises.
Other: PREDU Exercise Program

The intervention includes a supervised, multimodal therapeutic exercise program in two phases: 2 weeks before chemotherapy and 16 weeks during chemotherapy.

Pre-chemotherapy (2 weeks): 3 weekly home-based aerobic sessions and 2 supervised strength sessions (30 min each) using free weights or guided equipment.

During chemotherapy (16 weeks): 3 supervised sessions per week combining aerobic and strength training (20-50 min each). Aerobic exercises use stationary cycling or treadmill moderate continuous (70% HRmax) and interval training (Low HIIT 85%HRmax). Strength exercises are 2 sets of 8-12 reps at 50-80% of 1RM, using guided weights and elastic bands.

The program is adapted and planned according to participants' fatigue and chemotherapy cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI)
Time Frame: Evaluation at the start of chemotherapy (2 weeks after the beginning of the PREDU intervention) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Percentage of relative dose intensity (RDI), calculated as the ratio between planned chemotherapy dose and administered dose, expressed as a percentage. Data are obtained from medical clinical records. Compare the results between the groups.
Evaluation at the start of chemotherapy (2 weeks after the beginning of the PREDU intervention) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Complete Response (CR) Rate according to RECIST 1.1 Criteria
Time Frame: CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Percentage of participants achieving complete response (CR), defined as the disappearance of all target lesions and reduction of pathological lymph nodes to <10 mm, assessed using the RECIST 1.1 criteria scale. Data are obtained from medical clinical records. Compare the results between the groups.
CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-Related Fatigue Score assessed by Piper Fatigue Scale
Time Frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Fatigue is measured using the Piper Fatigue Scale, a self-reported instrument with 22 items scored from 0 to 10, where higher scores indicate greater fatigue. The scale evaluates four dimensions of subjective fatigue: severity, sensory impact, cognitive impact, and mood. The total fatigue score is calculated by summing the scores of the four dimensions and dividing by four. Measured on a numerical scale from 0 to 10. Compare the results of the four assessments and between the groups.
Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Static muscle strenght (kg) assessed by Handheld Dynamometer
Time Frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Peak muscle strength, expressed in kilograms (kg), assessed using a handheld dynamometer. Comparisons are made across all four assessments and between the groups.
Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Dynamic Muscle Strength (kg) using Brzycki Equation
Time Frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Estimated dynamic muscle strength, expressed in kilograms (kg), calculated from n-repetition maximum (n-RM) using the Brzycki equation.
Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Change in Quality of Life Score
Time Frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are on a 0-100 scale, with higher scores indicating better functioning or quality of life, whereas for symptom scales, higher scores indicate greater symptom burden. Compare the results of the four assessments and between the groups.
Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Change in Cardiorespiratory Capacity
Time Frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Cardiorespiratory capacity is assessed using the 6-Minute Walk Test (6MWT), a submaximal field test in which participants walk the greatest distance possible in 6 minutes along a 30-meter flat course. Exercise tolerance is evaluated through the distance walked (meters) and estimated VO₂max. Higher values indicate better cardiorespiratory fitness. Assessments are conducted at all four time points, and results are compared between the groups.
Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of Participants in Each Stage of Change Physical Activity Adherence
Time Frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of participants in each stage of change for physical activity, assessed using the Transtheoretical Model. Data are collected at each assessment point and compared between the control and experimental groups.
Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of Participants by Physical Activity Adherence Level
Time Frame: Assessed at baseline and at 24 weeks after completion of the intervention.
Percentage of participants achieving each level of moderate and vigorous physical activity (minutes per week), assessed and compared between the control and experimental groups to evaluate changes in adherence to physical activity.
Assessed at baseline and at 24 weeks after completion of the intervention.
To explore whether tumor location, stage, and age moderate the effect of the intervention on treatment tolerance and efficacy
Time Frame: Assessments are conducted from the first evaluation up to the third evaluation at 18 weeks.
Compare the primary and secondary outcome results by tumor location, stage, and age to explore whether outcomes differ between these subgroups.
Assessments are conducted from the first evaluation up to the third evaluation at 18 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vic - Central University of Catalonia

Collaborators

Col·legi Fisioterapeutes de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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