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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Adapted exercises; Behavioral: Quality of Life questionnaire; Behavioral: Questionnaire of Fatigue; Behavioral: Physical activity questionnaire; Behavioral: Physical condition; Other: No intervention

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyne Grinand, PhD; Phone Number: (+33)432759392; Email: grinand.marilyne@ch-avignon.fr
• Study Contact Backup: Name: Emmanuelle Guilie, APA; Phone Number: (+33)432759300; Email: guilie.emmanuelle@ch-avignon.fr

Study Locations

• France
  • Avignon, France
    • Recruiting
    • Centre Hospitalier d'Avignon, Hôpital Henri Duffaut
    • Sub-Investigator: Safia Chebrek, MD
    • Contact: Marilyne Grinand, PhD; Phone Number: (+33)0432759392; Email: grinand.marilyne@ch-avignon.fr
    • Principal Investigator: Emmanuelle Guilie, APA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: Quality of Life questionnaire; QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation; Behavioral: Questionnaire of Fatigue; Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation; Behavioral: Physical activity questionnaire; Questionnaire (IPAQ) at baseline and after transplantation; Behavioral: Physical condition; Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation; Other Names: 6 minutes walk test; 30s chair-stand test; Handgrip strength test; Other: No intervention; Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.
Experimental: APA group	Other: Adapted exercises; 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.; Behavioral: Quality of Life questionnaire; QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation; Behavioral: Questionnaire of Fatigue; Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation; Behavioral: Physical activity questionnaire; Questionnaire (IPAQ) at baseline and after transplantation; Behavioral: Physical condition; Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation; Other Names: 6 minutes walk test; 30s chair-stand test; Handgrip strength test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Evaluate the effect of the APA program on fatigue status.	Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of the APA program on quality of life.	Quality of Life of Cancer Patients : EORTC QLQ-C30 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).	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)
Fitness assessment.	6-minute walk test.	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)
Fitness assessment.	30-second chair-stand test.	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)
Fitness assessment.	Hand grip strength test.	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)
Nutritional status.	BMI.	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)
Grade III-IV adverse events rate.	According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From inclusion to assessment after transplant (on average about 30 weeks after inclusion)
Comparison of hospitalization length.	Hospitalization time (in days) after autologous stem cell transplantation.	Assessment after transplant (on average about 30 weeks after inclusion)
15. Attraction to sport assessment.	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)	Assessment after transplant (on average about 30 weeks after inclusion)
Adherence rate.	Percentage of patients who participated and validated more than 66 percent of the APA sessions recommended by the program.	Assessment after transplant (on average about 30 weeks after inclusion)
Attrition rate.	Percentage of patients who discontinued the program during the course of the study among patients who received an autologous stem cell transplantation.	Assessment after transplant (on average about 30 weeks after inclusion)
Rate of effective APA sessions.	Number of validated APA sessions divided by the number of planned sessions.	Assessment after transplant (on average about 30 weeks after inclusion)
Reasons for discontinuing the APA program.	Self-reported reasons for discontinuation	Assessment after transplant (on average about 30 weeks after inclusion)
Patient's comments and remarks.	Patient's follow-up notebook.	100 days after transplant
Patient satisfaction.	Satisfaction questionnaire. Likert-type scale (minimum = 0, maximum = 4, higher score means better outcome).	100 days after transplant

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Duffaut - Avignon

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Fatigue; Autologous stem cell transplantation; Adapted Physical Activity
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Fatigue; Multiple Myeloma
• Other Study ID Numbers: PREHAB-APA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No