Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy

NCT ID: NCT03252821

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2019-09-20

Brief Summary

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The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy.

A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.

Detailed Description

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Conditions

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Prostate Cancer Head and Neck Cancer Rectum Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High-intensity aerobic training group

High intensity interval training

Group Type EXPERIMENTAL

High-intensity interval training

Intervention Type BEHAVIORAL

High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.

Resistance training group

Muscle strengthening

Group Type ACTIVE_COMPARATOR

Resistance training

Intervention Type BEHAVIORAL

Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).

Control group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-intensity interval training

High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.

Intervention Type BEHAVIORAL

Resistance training

Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;
* age over 18 years;
* no distant metastases and/or disease progression;
* at least 25 scheduled radiation treatments (5 weeks);
* ability to read, write, and speak French.

Exclusion Criteria

* uncontrolled cardiac, hypertensive or pulmonary diseases,
* uncontrolled insulin-dependent diabetes mellitus,
* neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation
* abnormal electrocardiogram.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Caty Gilles

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Piraux E, Reychler G, Vancraeynest D, Geets X, Leonard D, Caty G. High-intensity aerobic interval training and resistance training are feasible in rectal cancer patients undergoing chemoradiotherapy: a feasibility randomized controlled study. Rep Pract Oncol Radiother. 2022 May 19;27(2):198-208. doi: 10.5603/RPOR.a2022.0036. eCollection 2022.

Reference Type DERIVED
PMID: 36299392 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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