Feasibility of an Adapted Physical Activity Program for Patients Treated With an Autograft (APA²)

NCT ID: NCT04320420

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2024-10-31

Brief Summary

Therapeutic intensification followed by an autograft of hematopoietic stem cells is a standard of care for young patients with myeloma from the first line and for lymphoma from the second or third line of treatment. This procedure remains toxic in the short and medium term with significant mortality and morbidity: the average mortality varies from 1.4 to 5%. The causes of death are linked to a severe infection, visceral bleeding or vital organ failure. This risk of mortality is partly correlated with sarcopenia.

Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.

The positive impact of adapted physical activity (APA) has been shown in numerous publications on reducing the incidence and risk of relapse for several cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on APA with different physical activity programs depending on the time of the intervention or according to the type, duration and intensity.

The objective of this study is to assess the feasibility of an APA program in patients requiring an autologous hematopoietic stem cell transplant. It is expected that the program will have a protective effect on the appearance of induced sarcopenia and on the complications related to the procedure in the short and medium term regardless of the hematology center for patients receiving intensive treatment with support for autologous hematopoietic stem cells.

This is a feasibility study.

Conditions

Myeloma; Lymphoma; Autologous Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental arm

The APA program is defined in 3 stages:

STEP 1: during the initial chemotherapy over 3 months

• 3 supervised APA sessions/week on site:

• two muscle strengthening sessions, stretching, flexibility in the gym
• a cardio session (Nordic Walking: outdoors)
• at home: exercise book if the patient wishes

STEP 2: during hospitalization for the autograft, over 1 month:

• 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work
• If the patient wishes, he can continue the exercises carried out with the APA engineer independently

STEP 3: after the transplant

• the first 3 months:

• 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility),
• 1-hour cardio session/week independently
• the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions

Group Type: EXPERIMENTAL

Adapted Physical Activity

Intervention Type: OTHER

The APA program is defined in 3 stages:

STEP 1: during the initial chemotherapy over 3 months

• 3 supervised APA sessions/week on site:

• two muscle strengthening sessions, stretching, flexibility in the gym
• a cardio session (Nordic Walking: outdoors)
• at home: exercise book if the patient wishes

STEP 2: during hospitalization for the autograft, over 1 month:

• 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work
• If the patient wishes, he can continue the exercises carried out with the APA engineer independently

STEP 3: after the transplant

• the first 3 months:

• 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility),
• 1-hour cardio session/week independently
• the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions

Interventions

Adapted Physical Activity

The APA program is defined in 3 stages:

STEP 1: during the initial chemotherapy over 3 months

• 3 supervised APA sessions/week on site:

• two muscle strengthening sessions, stretching, flexibility in the gym
• a cardio session (Nordic Walking: outdoors)
• at home: exercise book if the patient wishes

STEP 2: during hospitalization for the autograft, over 1 month:

• 2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work
• If the patient wishes, he can continue the exercises carried out with the APA engineer independently

STEP 3: after the transplant

• the first 3 months:

• 2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility),
• 1-hour cardio session/week independently
• the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years,

2. Patient with lymphoma or myeloma justifying an autograft of hematopoietic stem cells whatever the line of treatment,

3. Patient affiliated to a social security scheme,

4. Patient who has given written consent before any specific procedure related to the study

Exclusion Criteria

1. Central and / or peripheral neurological deficit not allowing adapted physical activity sessions to be carried out,

2. Uncontrolled hypertension,

3. Left ventricular Ejection Fraction <50%,

4. Chronic respiratory insufficiency with alterations in the functional respiratory investigations,

5. Active viral infection: hepatitis B, C and HIV,

6. Pregnancy or breastfeeding,

7. Persons deprived of their liberty or under guardianship

8. Dementia, mental alteration or psychiatric pathology which could compromise the patient's informed consent and / or compliance with the protocol and follow-up of the trial,

9. Patient who can't follow protocol for psychological, social, family or geographic reasons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weprom

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katell LE DU, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Bernard/Clinique Victor Hugo

Locations

CHU

Angers, , France

Site Status: NOT_YET_RECRUITING

Centre Jean Bernard/Clinique Victor Hugo

Le Mans, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Magali BALAVOINE

Role: CONTACT

m.balavoine@weprom.fr

241682940 ext. 0033

Facility Contacts

Aline SCHMITD, MD

Role: primary

LE DU Katell, MD

Role: primary

Other Identifiers

2019-A02203-54

Identifier Type: OTHER

Identifier Source: secondary_id

WP-2019-05

Identifier Type: -

Identifier Source: org_study_id