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NCT Number: NCT06789003

Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment

Adapted physical activity for patients with haematological malignancies generally has positive effects on quality of life, fatigue and physical condition. However, some studies show little or no effect.

This may be explained by inefficient protocols, but also by low rates of patient acceptability regarding the proposed exercises.

The multiplicity of APA protocols and the fluctuation of their results mean that validity, methodology and effects on patients need to be verified before they can be considered for implementation in healthcare services. A program must prove its feasibility, but patients must also adhere to it.

Acceptability can be measured by adherence, which represents the number of validated sessions in relation to the number of planned sessions, and by attrition, which corresponds to the number of stops or drop-outs for any reason. The various APA programs offered in the context of intensive auto or allograft treatment are limited, notably by adherence, which can fall by as much as 24%, and attrition, which can be as high as 67%. Optimization of the proposed exercises and follow-up methods is therefore necessary in order to propose an APA program that will be feasible, effective and acceptable to a maximum number of patients.

To meet these objectives for patients with multiple myeloma eligible for autologous stem cell transplantation, the protocol for this study took into consideration the various recommendations of previous publications and the guidelines from HAS (French National Authority for Health).

The ultimate goal of this study is to validate, in terms of effectiveness and acceptability, the methodology and in particular the use of new specific tools for optimizing an APA program. It will subsequently be offered to all patients with multiple myeloma eligible for autologous stem cell transplantation, independently of their age or physical condition, while respecting their rhythm and physical condition.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, France

Location status: Recruiting

Location contact

Emmanuelle Guilie, APA

PRINCIPAL_INVESTIGATOR

Marilyne Grinand, PhD

CONTACT

[email protected]

(+33)0432759392

Safia Chebrek, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old.
  • CML patient in chronic phase, eligible for oral therapy.
  • Diagnosis of multiple myeloma.
  • Patient eligible for autologous stem cell transplantation.
  • Patient capable to read, understand and complete a questionnaire in french.
  • WHO less than or equal to 2.
  • Patient affiliated with french social security.
  • Patient with a medical prescription for APA.

Exclusion criteria

  • Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).
  • Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)
  • Sensory or motor neuropathy.
  • Patient deprived of liberty, under guardianship or curatorship.
  • Patient considered socially or psychologically unfit to be enrolled in a study.

Treatment and study plan

Adapted exercises

Other

Patients will have 3 sessions a week: 1 strengthening session and 2 endurance sessions.

For each session, patients will choose the exercises to be performed from the exercise booklet or the videos and records their observations in the patient notebook.

Depending on the treatment plan, patients will have alternating supervised (in hospital) and unsupervised (at home) APA sessions, in order to follow the rhythm of their visits to the department.

Each session will last 45 minutes with a medium intensity according to the Borg scale.

No intervention

Other

Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.

Quality of Life Questionnaire

Behavioral

QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation

Questionnaire of Fatigue

Behavioral

Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation

Physical activity questionnaire

Behavioral

Questionnaire (IPAQ) at baseline and after transplantation

Physical condition

Behavioral

Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation

Other names: 30s chair-stand test, Handgrip strength test, 6 minutes walk test

Primary outcomes

  1. 1. Evaluate the effect of the APA program on fatigue status.

    Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)

    Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).

Secondary outcomes

  1. Evaluate the effect of the APA program on quality of life.

    Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)

    Quality of Life of Cancer Patients : EORTC QLQ-C30 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).

  2. Fitness assessment.

    Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)

    6-minute walk test.

  3. Fitness assessment.

    Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)

    30-second chair-stand test.

  4. Fitness assessment.

    Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)

    Hand grip strength test.

  5. Nutritional status.

    Time frame: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)

    BMI.

  6. Grade III-IV adverse events rate.

    Time frame: From inclusion to assessment after transplant (on average about 30 weeks after inclusion)

    According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  7. Comparison of hospitalization length.

    Time frame: Assessment after transplant (on average about 30 weeks after inclusion)

    Hospitalization time (in days) after autologous stem cell transplantation.

  8. 15. Attraction to sport assessment.

    Time frame: Assessment after transplant (on average about 30 weeks after inclusion)

    IPAQ questionnaire (continuous score expressed as MET-min per week: MET level x minutes of activity/day x days per week, higher score means better outcome)

  9. Adherence rate.

    Time frame: Assessment after transplant (on average about 30 weeks after inclusion)

    Percentage of patients who participated and validated more than 66 percent of the APA sessions recommended by the program.

  10. Attrition rate.

    Time frame: Assessment after transplant (on average about 30 weeks after inclusion)

    Percentage of patients who discontinued the program during the course of the study among patients who received an autologous stem cell transplantation.

  11. Rate of effective APA sessions.

    Time frame: Assessment after transplant (on average about 30 weeks after inclusion)

    Number of validated APA sessions divided by the number of planned sessions.

  12. Reasons for discontinuing the APA program.

    Time frame: Assessment after transplant (on average about 30 weeks after inclusion)

    Self-reported reasons for discontinuation

  13. Patient's comments and remarks.

    Time frame: 100 days after transplant

    Patient's follow-up notebook.

  14. Patient satisfaction.

    Time frame: 100 days after transplant

    Satisfaction questionnaire. Likert-type scale (minimum = 0, maximum = 4, higher score means better outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle Guilie, APA

CONTACT

[email protected]

(+33)432759300

Marilyne Grinand, PhD

CONTACT

[email protected]

(+33)432759392

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Duffaut - Avignon

Other

Registry information

Official study title

Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment (PREHAB-APA)

Acronym: PREHAB-APA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 23, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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