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Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA)

Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) at Institut de Cancerologie de l'Ouest (ICO)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04675814
Acronym
APA
Enrollment
37
Registered
2020-12-19
Start date
2020-09-14
Completion date
2021-03-14
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sports Physical Therapy

Keywords

Adapted Physical Activity program (APA), kinesiophobia, Fatigue, Quality of life

Brief summary

The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

Detailed description

The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment. A 12-week Adapted Physical Activity program (APA) is proposed to patients included in the study with an assessment of fatigue, quality of life, level of physical activity and kinesiophobia (fear of movement) at the beginning of the study. A second assessment of fatigue and quality of life will be done during the 6-week management. At the end of the program, a final evaluation of fatigue, quality of life and kinesiophobia will be done.

Interventions

Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy). The APA program duration is : 12 weeks

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Oncological care at the ICO 2. All types of cancer 3. Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy) 4. Age \> 18 years old 5. Follow the APA program at the ICO 6. Subject informed of the study

Exclusion criteria

1. Contraindication to the practice of sport 2. APA Program outside the ICO 3. Subject opposing the use of his data 4. Minor or adult patient under guardianship or curatorship 5. Pregnant woman 6. Altered general condition

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.12 weeksDescribe the evolution of the quality of life of patients being treated for their cancer pathology at the ICO site in Angers, and participating in the 12-week adapted physical activity program at ICO. Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. The questionnaire is structured into five sections, each containing between 6 and 13 items. In total, it includes 40 items, each scored from 0 to 4: 0 - Not at all 1. \- A little 2. \- Moderately 3. \- Quite a bit 4. \- Very much By adding up the answers, the score range obtained is: 0 to 160. The higher the score, the less tired the patient is.

Secondary

MeasureTime frameDescription
Describe Attendance at the APA Program.12 weeksThe number of sessions is planned by the APA coach at the beginning of the APA program. The number of performed sessions is measured.
Measure the Evolution of Kinesiophobia (Fear of Movement).12 weeksKinesiophobia is measured with the TAMPA Scale for Kinesiophobia (TSK-CF). This scale assesses the kinesiophobia index presented by the patient at the time of the assessment. The higher the score, the greater the level of kinesiophobia. Total score range: 17 to 68. Higher scores indicate greater fear of movement. A score ≥ 40 is considered significant kinesiophobia.
Measure Physical Activity at the Initiation of the APA Program.Week 0The level of physical activity (PA) is assessed using the GPAQ questionnaire. The questionnaire consists of 16 items. Physical activity is expressed in MET-minutes per week (Metabolic Equivalent of Task), calculated from reported activity. Based on the score, three profiles are defined: High * ≥3 days vigorous activity (≥1500 MET-min/week) OR * ≥7 days walking/moderate/vigorous PA (≥3000 MET-min/week) Moderate * ≥20 min vigorous PA / day, ≥3 days/week OR * ≥30 min moderate PA/walking / day, ≥5 days/week OR * ≥5 days mixed activity (≥600 MET-min/week) Low * Does not meet above criteria

Countries

France

Contacts

STUDY_CHAIRSophie ABADIE-LACOURTOISIE, MD

Institut de Cancérologie de l'Ouest

Participant flow

Recruitment details

Study start date first signed consent: 14 SEP 2020 Date of first patient inclusion: 14 SEP 2020 End of trial date (last visit of last patient): 14 MAR 2021

Pre-assignment details

All screened patients have been included

Baseline characteristics

Characteristic
Age, Continuous52.7 Years
STANDARD_DEVIATION 11.5
Region of Enrollment
France
37 Participants
Sex: Female, Male
Female
30 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026