How to Carry on an Effective Community Program of Exercice-oncology.

NCT05078216 | Completed DMC

• 1 other identifier: CEI PI 23_2021-v4
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise-oncology is an emerging area, but exist a lack of information about an effective methodology to establish counseling programs long-lasting and not based on research objectives. This observational study objective was to evaluate the feasibility and effective exercise-oncology community intervention in a real patients sample.

Conditions

Cancer Patients in Different Stages

Keywords

exercise-oncology,; physical activity intervention; quality of life

Outcome Measures

Primary Outcomes (1)

• Feasibility of an exercise-oncology program

  to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians.

  12 weeks

Secondary Outcomes (1)

• Effective dose-response, safeness and adherence

  12 weeks

Study Arms (1)

Cancer patients

The exercise program consisted of a 12-week supervised intervention, with twice per week sessions of 90 minutes, and was developed in a friendly and close environment, which promoted social interaction between participants. Apart from the twice-weekly supervised sessions, as early as the fifth week, one or two individualized home-based sessions were established for each patient in order to achieve his/her specific objectives with the help of any required supporting material such as documents and video references with exercise examples. All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR)

Other: Physical exercise intervention

Interventions

Physical exercise intervention OTHER

12-week supervised intervention, 90 minutes sessions twice per week All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR). Fitness work in the first eight sessions was planned following 30 min of time on cardiovascular exercise 55 min on work out in low to moderate intensity. In the next eight sessions, the time spent on cardiovascular work was slightly increased to 35 min, with 50 min focused on work out, combining moderate to high-intensity sessions. The last eight sessions presented the same structure as the first ones but combining moderate to high intensity.

Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three different type of cancer patients were included: 1. patients that recently finished their treatments but still presented secondary effects (patients under hormonotherapy are included here); 2. patients under chemotherapy, radiotherapy or target therapy treatments; 3. patients with advanced or metastatic cancer

You may qualify if:

• Being a cancer patient
• Being over 18 years
• Having an Eastern Cooperative Oncology Group (ECOG)≤1,
• Being e able to walk 500 meters without resting
• Feeling or presenting any physical side effect related to cancer treatments, like weakness, fatigue, change in body composition, and/or physical pain, without significant clinical implications

You may not qualify if:

• Presenting any physical or psychological disability
• Having an ejection fraction below 50%
• Having any American Thoracic Society recommendations to not develop a Cardio Pulmonary Exercise Test
• Present joint limitations with need of rehabilitation exercise, grade 1-2 lymphedema
• Presenting active bone metastasis.

Sponsors & Collaborators

• Asociación Española contra el Cáncer: lead

Study Sites (1)

Spanish Cancer Association

Madrid, 28040, Spain

Location

Related Publications (6)

• Ferioli M, Zauli G, Martelli AM, Vitale M, McCubrey JA, Ultimo S, Capitani S, Neri LM. Impact of physical exercise in cancer survivors during and after antineoplastic treatments. Oncotarget. 2018 Feb 8;9(17):14005-14034. doi: 10.18632/oncotarget.24456. eCollection 2018 Mar 2.

  PMID: 29568412 RESULT

• Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

  PMID: 20559064 RESULT

• 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.

  PMID: 31626055 RESULT

• Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, Ligibel JA, Cheville A, Galvao DA, Alfano CM, Patel AV, Hue T, Gerber LH, Sallis R, Gusani NJ, Stout NL, Chan L, Flowers F, Doyle C, Helmrich S, Bain W, Sokolof J, Winters-Stone KM, Campbell KL, Matthews CE. Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer. CA Cancer J Clin. 2019 Nov;69(6):468-484. doi: 10.3322/caac.21579. Epub 2019 Oct 16.

  PMID: 31617590 RESULT

• Pollan M, Casla-Barrio S, Alfaro J, Esteban C, Segui-Palmer MA, Lucia A, Martin M. Exercise and cancer: a position statement from the Spanish Society of Medical Oncology. Clin Transl Oncol. 2020 Oct;22(10):1710-1729. doi: 10.1007/s12094-020-02312-y. Epub 2020 Feb 13.

  PMID: 32052383 RESULT

• GilHerrero L, Courneya KS, McNeely ML, Castellanos M, Gonzalez Marquez AI, Pollan M, Casla-Barrio S. Effects of a Clinical Exercise Program on Health-Related Fitness and Quality of Life in Spanish Cancer Patients Receiving Adjuvant Therapy. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221141715. doi: 10.1177/15347354221141715.

  PMID: 36565156 DERIVED

Study Officials

• Soraya Casla Barrio, Phd

  Asociación Española contra el Cáncer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Exercise physiologist

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 14, 2021
• Study Start: September 1, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)