Sports Physical TherapyAPANCT04675814
Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA)
An observational study of Sports Physical Therapy, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Adapted Physical Activity (APA)
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2020to 14 Mar 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects participating in the ICO's APA program during the enrolment period regardless of the type of cancer and the type of treatment in progress (chemotherapy, radiotherapy, hormone therapy, immunotherapy) who accept to participate to the study.
Who may be able to join
- Oncological care at the ICO
- All types of cancer
- Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
- Age > 18 years old
- Follow the APA program at the ICO
- Subject informed of the study
Who cannot join
- Contraindication to the practice of sport
- APA Program outside the ICO
- Subject opposing the use of his data
- Minor or adult patient under guardianship or curatorship
- Pregnant woman
- Altered general condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Sports Physical Therapy
- Being tested
- Adapted Physical Activity (APA)
- Keywords
- Adapted Physical Activity program (APA), kinesiophobia, Fatigue, Quality of life
- Medical subject headings
- Kinesiophobia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity (APA)Other
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.
Describe 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
- - A little
- - Moderately
- - Quite a bit
- - 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.
Measured: 12 weeks
Secondary outcomes (3)
Describe Attendance at the APA Program.
The number of sessions is planned by the APA coach at the beginning of the APA program. The number of performed sessions is measured.
Measured: 12 weeks
Measure the Evolution of Kinesiophobia (Fear of Movement).
Kinesiophobia 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.
Measured: 12 weeks
Measure Physical Activity at the Initiation of the APA Program.
The 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
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start14 Sep 2020
- Primary completion14 Mar 2021
- Study completion14 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie ABADIE-LACOURTOISIE, MD, Study chair, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675814
- Sponsor's protocol ID
- ICO-2020-05
- Acronym
- APA
- Status last verified
- May 2021
- First submitted
- 1 Dec 2020
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04675814
- Acronym / sponsor ID
- APA / ICO-2020-05
- Conditions
- Sports Physical Therapy
- Keywords
- Adapted Physical Activity program (APA), kinesiophobia, Fatigue, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in the ICO's APA program during the enrolment period regardless of the type of cancer and the type of treatment in progress (chemotherapy, radiotherapy, hormone therapy, immunotherapy) who accept to participate to the study.
Key inclusion criteria (6 listed)
- Oncological care at the ICO
- All types of cancer
- Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
- Age > 18 years old
- Follow the APA program at the ICO
Key exclusion criteria (6 listed)
- Contraindication to the practice of sport
- APA Program outside the ICO
- Subject opposing the use of his data
- Minor or adult patient under guardianship or curatorship
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical Activity (APA)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 | Other | – |
Primary outcome
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.
Time frame: 12 weeks
Describe 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.
3 secondary outcomes
Describe Attendance at the APA Program.
Time frame: 12 weeks
Measure the Evolution of Kinesiophobia (Fear of Movement).
Time frame: 12 weeks
Measure Physical Activity at the Initiation of the APA Program.
Time frame: Week 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie ABADIE-LACOURTOISIE, MD study chair
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Physical Therapy, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.