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CompletedNCT04675814APAUpdated Jan 27, 2026Results posted

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

An observational study in Sports Physical Therapy, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Institut Cancerologie de l'Ouest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
37
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sports Physical Therapy

Keywords

  • Adapted Physical Activity program (APA)
  • kinesiophobia
  • Fatigue
  • Quality of life
03

In context

Kinesiophobia

243 studies on the registry are indexed under Kinesiophobia; 89 are open to participants now.

This study's enrollment of 37 is below the median of 77 across 98 observational studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
37 participants (actual)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • OtherAdapted 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

06

What researchers measure

Primary outcomes

  1. 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 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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

    Time frame: Week 0

07

Results

Posted Jan 27, 2026

Participant flow

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

Participant flow — Overall Study
MilestoneAdapted Physical Activity (APA)
Started37
Completed33
Not completed4
Withdrew: Withdrawal by subject3
Withdrew: Performance status alteration not related to study procedure1

Outcome measures

PrimaryQuality 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 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.
score on a scaleAdapted Physical Activity (APA)
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.117.6 ± 23.5
SecondaryDescribe 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.

Time frame:
12 weeks
Reported as:
Mean · Number of APA sessions
Describe Attendance at the APA Program.
Number of APA sessionsAdapted Physical Activity (APA)
Describe Attendance at the APA Program.14.2 ± 6.3
SecondaryMeasure 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.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Measure the Evolution of Kinesiophobia (Fear of Movement).
score on a scaleAdapted Physical Activity (APA)
Measure the Evolution of Kinesiophobia (Fear of Movement).34.45 ± 6.02
SecondaryMeasure 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

Time frame:
Week 0
Reported as:
Count of participants · Participants
Measure Physical Activity at the Initiation of the APA Program.
ParticipantsAdapted Physical Activity (APA)
High activity level1
Moderate activity level19
Low activity level17

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Adapted Physical Activity (APA)———

Baseline characteristics

Cancer patients

Age, Continuous
Age, Continuous(Years)Adapted Physical Activity (APA)
Mean52.7 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Adapted Physical Activity (APA)
Female30
Male7
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Adapted Physical Activity (APA)
Region of Enrollment
Region of Enrollment(Participants)Adapted Physical Activity (APA)
France37
08

Study locations

1 site
  • Institut de Cancérologie de L'Ouest
    Angers, 49055, France
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 6, 2020

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04675814
Lead sponsor
Institut Cancerologie de l'Ouest
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
Sep 14, 2020
Primary completion
Mar 14, 2021
Completion
Mar 14, 2021
Results posted
Jan 27, 2026
Last update
Jan 27, 2026

Study contacts

Sophie ABADIE-LACOURTOISIE, MD
study chair · Institut de Cancérologie de l'Ouest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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