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| Name | Class |
|---|---|
| Col·legi Fisioterapeutes de Catalunya | UNKNOWN |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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. |
|
| Experimental group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREDU Exercise Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI) | 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 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-Related Fatigue Score assessed by Piper Fatigue Scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meritxell Parareda Ventura, Physiotherapist | Contact | (+34) 93 881 60 25 | meritxell.parareda@uvic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Hospitalari de Vic | Vic | Barcelona | 08500 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40788186 | Background | Kjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416. | |
| 40447136 |
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A randomized clinical trial with blinded outcomes assessor, longitudinal and prospective design is proposed, in accordance with the CONSORT 2025 guidelines.
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|
| Recommendation Exercise Program | Other | 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. |
|
| 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 | 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 | 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 | 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 | 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 VOâ‚‚max. 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 | 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 | 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 | 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. |
| Facultat de Ciències de la Salut i del Benestar de la Universitat de Vic (UVIC-UCC) Universitat de Vic- Universitat Central de Catalunya | Vic | Barcelona | 08500 | Spain |
|
| Hospital Universitari de la Santa Creu | Vic | Barcelona | 08500 | Spain |
|
| Background |
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| 29247584 | Background | Ormel HL, van der Schoot GGF, Sluiter WJ, Jalving M, Gietema JA, Walenkamp AME. Predictors of adherence to exercise interventions during and after cancer treatment: A systematic review. Psychooncology. 2018 Mar;27(3):713-724. doi: 10.1002/pon.4612. Epub 2018 Jan 26. |
| 33807611 | Background | But-Hadzic J, Dervisevic M, Karpljuk D, Videmsek M, Dervisevic E, Paravlic A, Hadzic V, Tomazin K. Six-Minute Walk Distance in Breast Cancer Survivors-A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2021 Mar 5;18(5):2591. doi: 10.3390/ijerph18052591. |
| 36444224 | Background | van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov. |
| 34961754 | Background | Groen WG, Naaktgeboren WR, van Harten WH, van Vulpen JK, Kool N, Sonke GS, van der Wall E, Velthuis MJ, Aaronson NK, May AM, Stuiver MM. Physical Fitness and Chemotherapy Tolerance in Patients with Early-Stage Breast Cancer. Med Sci Sports Exerc. 2022 Apr 1;54(4):537-542. doi: 10.1249/MSS.0000000000002828. |
| 31626055 | Background | Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116. |
| 35278203 | Background | Ficarra S, Thomas E, Bianco A, Gentile A, Thaller P, Grassadonio F, Papakonstantinou S, Schulz T, Olson N, Martin A, Wagner C, Nordstrom A, Hofmann H. Impact of exercise interventions on physical fitness in breast cancer patients and survivors: a systematic review. Breast Cancer. 2022 May;29(3):402-418. doi: 10.1007/s12282-022-01347-z. Epub 2022 Mar 12. |
| 35715631 | Background | Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17. |
| 38564089 | Background | Lin D, Sturgeon KM, Muscat JE, Zhou S, Hobkirk AL, O'Brien KM, Sandler DP, Thompson CL. Associations of pre-diagnosis physical activity with treatment tolerance and treatment efficacy in breast cancer patients with neoadjuvant chemotherapy. Breast Cancer. 2024 May;31(3):519-528. doi: 10.1007/s12282-024-01569-3. Epub 2024 Apr 2. |
| 31877085 | Background | Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |
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