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

NCT04320420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-10-08

No results posted yet for this study

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

Interventions

OTHER

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

Sponsors & Collaborators

  • Weprom

    lead OTHER

Principal Investigators

  • Katell LE DU, MD · Centre Jean Bernard/Clinique Victor Hugo

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2023-04-30
Completion
2024-10-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320420 on ClinicalTrials.gov