Actively Recruiting
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2025-03-17
90
Participants Needed
1
Research Sites
N/A
Total Duration
C
Centre Hospitalier Régional Metz-Thionville
Lead Sponsor
U
University of Lorraine
Collaborating Sponsor
This research aims to evaluate the effects of Adapted Physical Activity (APA) programs on reducing state anxiety and improving functional capacities in people with severe blood cancers admitted to the Intensive Care Unit (ICU). Anxiety is a major concern for these patients, and the study compares traditional APA, APA combined with Exergaming, and APA with biofeedback relaxation to see if any approach offers additional benefits. The goal is to lessen anxiety and psychological fatigue while maintaining or improving physical function. Participants are assigned to one of three groups practicing aerobic activity three times a week, with each session lasting 30 to 60 minutes at a light to moderate intensity. The groups include a classical APA group using a cyclo-ergometer, an APA group with Exergaming devices, and an APA group that combines exercise with biofeedback relaxation. Each session includes warm-up, training, and cool-down phases, with the relaxation group using a biofeedback device during cool-down to promote relaxation. During the study, functional capacities are measured at the start and end of the program using submaximal tests like the 2-minute Walk Test and the 5 Times Sit to Stand Test. Anxiety and fatigue levels are assessed with questionnaires such as the State Trait Anxiety Inventory and the Multi-Fatigue Inventory. Participants also provide feedback on satisfaction and adherence by comparing planned versus completed sessions. The study tracks changes in anxiety, physical performance, and quality of life throughout the intervention and shortly after discharge.
CONDITIONS
APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of hospital stay during high dose treatment in protected area
Participants engage in a supervised adapted physical activity (APA) program with relaxation techniques. Sessions occur 3 times per week, each lasting 30 to 60 minutes, including warm-up, aerobic training, and cool down with either stretching, exergaming, or biofeedback relaxation depending on group assignment.
3 sessions per week
Duration - Up to 1 month after intervention
Participants are assessed for changes in functional capacities, anxiety, fatigue, and quality of life immediately after the APA program and one month after intervention completion.
1 visit at program end and 1 visit one month later
Total: 1 location
1
CHR Metz-Thionville/Hopital de Mercy
Metz, France, 57085
Actively Recruiting
A
Arpiné EL NAR, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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Johanne Bousmia, Cécile Langlet, Arpiné Ardzivian Elnar...
https://pubmed.ncbi.nlm.nih.gov/41344711