AgedOCAPINCT04052126
An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies
A study testing Individualized physical activity program in people with Aged and Aged, 80 and Over, run by Centre Leon Berard at 1 site in France.
Trial summary
Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aged, Aged, 80 and Over, Leukemia, Myeloid, Acute
- What is being tested?
- Individualized physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2019to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 and over,
- With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML),
- Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination,
- Followed-up in one of the investigating centers,
- Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie,
- Having a ECOG < 3,
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- With a life expectancy > 6 months,
- Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician,
- Available and willing to participate in the study for the duration of the intervention and follow-up,
- Able to understand, read and write French,
- Affiliated with a social security scheme,
- Having dated and signed an informed consent.
Who cannot join
- Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
- Treated by immunotherapy alone,
- Participating in concurrent physical activity studies,
- Deprived of their liberty by court or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Prospective Study to Test the Feasibility of an Individualized Physical Activity Program in Patients Over 65 Years of Age With Hematologic Malignancies: the OCAPI Project.
Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.
OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG <3, with no contraindications to PA and no history or coexistence of other primary cancer.
Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.
- Conditions
- Aged, Aged, 80 and Over, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Exercise, Quality of Life
- Being tested
- Individualized physical activity program
- Medical subject headings
- Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized physical activity programOther
Participants who agreed to participate in the study will participate in an individualized 6-month physical activity (PA) program, consisting of 3 periods: initiation (1st month), transition (2nd-3rd months) and autonomy (4th-6th months). It is based on 4 PA modalities:
The supervised PA session in a sterile room or at home once a week during the initiation and transition phases (20-45 min, low-to-moderate intensity, walking, muscle strengthening, balance and flexibility exercises).
The unsupervised PA session in a sterile room or at home once a week during the transition phase and twice a week during the autonomy phase (same as supervised session).
Follow-up by telephone once a month during the autonomy phase (30 min, support to PA).
Continuously wearing an activity tracker throughout the entire program (promotion of walking).
Activities are planned over a period of 6 months to achieve an intervention that meets the key principles of progression, specificity and empowerment.
| Study group | Role | What they receive |
|---|---|---|
| Individualized physical activity program | Experimental | Not described Receives: Other: Individualized physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate of the physical activity sessions
Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions
Measured: 6 months
Compliance rate of the phone calls
Ratio of the number of phone calls performed / number of scheduled calls
Measured: 6 months
Compliance rate of the activity tracker
Ratio of the number of days wearing the activity tracker / number of days of the program
Measured: 6 months
Secondary outcomes (26)
Acceptability of the intervention
Ratio of number of patients included / number of eligible patients
Measured: At inclusion
Safety of the intervention
Number, type and timing of program-related adverse events
Measured: 6 months
Adherence of the intervention
Ratio of the number of patients still in the program / number of patients included in the study
Measured: 3 months and 6 months
Impact of the program on autonomy for activities of daily living
Activities of Daily Living questionnaire (ADL) - scale from 0 to 6, 0=autonomy; 6 = no autonomy
Measured: At inclusion, 3 months and 6 months
Impact of the program on autonomy for instrumental activities of daily living
Instrumental activities of Daily Living questionnaire (IADL) - scale from 0 to 4, 0=autonomy; 4 = no autonomy
Measured: At inclusion, 3 months and 6 months
Impact of the program on upper body strength
30-s Arm Curl Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on lower body strength
30-s Chair Stand Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on upper body flexibility
Back Scratch Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on lower body flexibility
Chair Sit and Reach Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on agility
Timed Up and Go Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on walking endurance
6-min Walk Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on walking speed
10-m Walk Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on balance
Open-eyes Unipodal Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on grip strength
Hand Grip Dynamometer Test
Measured: At inclusion, 3 months and 6 months
Impact of the program on anthropometrics
BMI (weight and height will be combined to report BMI in kg/m^2)
Measured: At inclusion, 3 months and 6 months
Impact of the program on nutrition
Mini Nutritional Assessment (MNA) - scale from 0 to 30 points; score<17=bad nutritional status ; 17 and 23.5=risk of malnutrition ; >24: adaptednutritional status
Measured: At inclusion, 3 months and 6 months
Impact of the program on cognition
Montreal Cognitive Assessment (MoCA) ; scale from 0 to 30; normal if score >16
Measured: At inclusion, 3 months and 6 months
Impact of the program on depression
Geriatric Depression Scale-15 (GDS-15) ; scale from 0 to 15 ; 0 to 5=normal ; 6 and 9 = high probability of depression ; > 9 = almost systematic depression
Measured: At inclusion, 3 months and 6 months
Impact of the program on self-efficacy
Self-efficacy for exercise scale - This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.
Measured: At inclusion, 3 months and 6 months
Impact of the program on comorbidities
Cumulativ Illness Rating Scale - Geriatric (CIRS-G) ; 14 items ; for each one, score from 0 to 4 : 0=no problem and 4=serious issue
Measured: At inclusion, 3 months and 6 months
Impact of the program on health-related quality of life
European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) - scale from 0 to 100
Measured: At inclusion, 3 months, 6 months and 1 year
Impact of the program on fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) ; score from 0 to 65 ; the higher the score is, the less the patient has fatigue
Measured: At inclusion, 3 months, 6 months and 1 year
Impact of the program on the level of physical activity
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) ; Godin scale score: < 14 units: insufficiently active/sedentary ; 14-23: moderately active ; 24 or more : active
Measured: At inclusion, 3 months, 6 months and 1 year
Impact of the program on exercise barriers
Barriers to Being Active Quiz
Measured: At inclusion, 3 months, 6 months and 1 year
Impact of the program on social vulnerability
Évaluation de la précarité et des inégalités de santé pour les CES (EPICES questionnaire) - scale from 0 to 100, 0= no social vulnerability, 100=max vulnerability, threshold=30
Measured: At inclusion and 1 year
Impact of the program on falls
Number of falls
Measured: At inclusion and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start28 Nov 2019
- Primary completion23 Nov 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle NICOLAS-VIRELIZIER, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052126
- Sponsor's protocol ID
- OCAPI
- Acronym
- OCAPI
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2019
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fournier B, Nicolas-Virelizier E, Russo C, Perol O, Millet GY, Maire A, Delrieu L, Michallet AS, Assaad S, Belhabri A, Gilis L, Guillermin Y, Lebras L, Rey P, Santana C, Pretet-Flamand E, Terret C, Michallet M, Fervers B. Individualised physical activity programme in patients over 65 years with haematological malignancies (OCAPI): protocol for a single-arm feasibility trial. BMJ Open. 2021 Jun 3;11(6):e046409. doi: 10.1136/bmjopen-2020-046409.
PubMed 34083339
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Prospective Study to Test the Feasibility of an Individualized Physical Activity Program in Patients Over 65 Years of Age With Hematologic Malignancies: the OCAPI Project.
- ClinicalTrials.gov ID
- NCT04052126
- Acronym / sponsor ID
- OCAPI / OCAPI
- Conditions
- Aged, Aged, 80 and Over, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Exercise, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.
OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG <3, with no contraindications to PA and no history or coexistence of other primary cancer.
Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized physical activity program | Experimental | Other: Individualized physical activity program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Age 65 and over,
- With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML),
- Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination,
- Followed-up in one of the investigating centers,
- Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie,
Key exclusion criteria (4 listed)
- Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
- Treated by immunotherapy alone,
- Participating in concurrent physical activity studies,
- Deprived of their liberty by court or administrative decision.
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 |
|---|---|---|
| Individualized physical activity programParticipants who agreed to participate in the study will participate in an individualized 6-month physical activity (PA) program, consisting of 3 periods: initiation (1st month), transition (2nd-3rd months) and autonomy (4th-6th months). It is based on 4 PA modalities: The supervised PA session in a sterile room or at home once a week during the initiation and transition phases (20-45 min, low-to-moderate intensity, walking, muscle strengthening, balance and flexibility exercises). The unsupervised PA session in a sterile room or at home once a week during the transition phase and twice a week during the autonomy phase (same as supervised session). Follow-up by telephone once a month during the autonomy phase (30 min, support to PA). Continuously wearing an activity tracker throughout the entire program (promotion of walking). Activities are planned over a period of 6 months to achieve an intervention that meets the key principles of progression, specificity and empowerment. | Other | Individualized physical activity program |
Primary outcome
Compliance rate of the physical activity sessions
Time frame: 6 months
Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions
Compliance rate of the phone calls
Time frame: 6 months
Ratio of the number of phone calls performed / number of scheduled calls
Compliance rate of the activity tracker
Time frame: 6 months
Ratio of the number of days wearing the activity tracker / number of days of the program
26 secondary outcomes
Acceptability of the intervention
Time frame: At inclusion
Safety of the intervention
Time frame: 6 months
Adherence of the intervention
Time frame: 3 months and 6 months
Impact of the program on autonomy for activities of daily living
Time frame: At inclusion, 3 months and 6 months
Impact of the program on autonomy for instrumental activities of daily living
Time frame: At inclusion, 3 months and 6 months
Impact of the program on upper body strength
Time frame: At inclusion, 3 months and 6 months
Impact of the program on lower body strength
Time frame: At inclusion, 3 months and 6 months
Impact of the program on upper body flexibility
Time frame: At inclusion, 3 months and 6 months
Impact of the program on lower body flexibility
Time frame: At inclusion, 3 months and 6 months
Impact of the program on agility
Time frame: At inclusion, 3 months and 6 months
Impact of the program on walking endurance
Time frame: At inclusion, 3 months and 6 months
Impact of the program on walking speed
Time frame: At inclusion, 3 months and 6 months
Impact of the program on balance
Time frame: At inclusion, 3 months and 6 months
Impact of the program on grip strength
Time frame: At inclusion, 3 months and 6 months
Impact of the program on anthropometrics
Time frame: At inclusion, 3 months and 6 months
Impact of the program on nutrition
Time frame: At inclusion, 3 months and 6 months
Impact of the program on cognition
Time frame: At inclusion, 3 months and 6 months
Impact of the program on depression
Time frame: At inclusion, 3 months and 6 months
Impact of the program on self-efficacy
Time frame: At inclusion, 3 months and 6 months
Impact of the program on comorbidities
Time frame: At inclusion, 3 months and 6 months
Impact of the program on health-related quality of life
Time frame: At inclusion, 3 months, 6 months and 1 year
Impact of the program on fatigue
Time frame: At inclusion, 3 months, 6 months and 1 year
Impact of the program on the level of physical activity
Time frame: At inclusion, 3 months, 6 months and 1 year
Impact of the program on exercise barriers
Time frame: At inclusion, 3 months, 6 months and 1 year
Impact of the program on social vulnerability
Time frame: At inclusion and 1 year
Impact of the program on falls
Time frame: At inclusion and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 34083339Fournier B, Nicolas-Virelizier E, Russo C, Perol O, Millet GY, Maire A, Delrieu L, Michallet AS, Assaad S, Belhabri A, Gilis L, Guillermin Y, Lebras L, Rey P, Santana C, Pretet-Flamand E, Terret C, Michallet M, Fervers B. Individualised physical activity programme in patients over 65 years with haematological malignancies (OCAPI): protocol for a single-arm feasibility trial. BMJ Open. 2021 Jun 3;11(6):e046409. doi: 10.1136/bmjopen-2020-046409.
- Individual participant dataSharing planned: No
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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.
Emmanuelle NICOLAS-VIRELIZIER principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized physical activity program in people with Aged and Aged, 80 and Over, run by Centre Leon Berard 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 12 inclusion and 4 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 30 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compliance rate of the physical activity sessions (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052126, which also lists 1 linked publication.
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 30 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.