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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05188755
Other study ID # RBHP 2021 KANOLD
Secondary ID 2021-A02184-37
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date December 6, 2022

Study information

Verified date November 2021
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Regular physical activity (PA) is associated with maintaining body composition, increased cardiorespiratory capacity, muscle mass and bone mineral density. In the event of a cancer, the development of physical capacities and metabolism may therefore be disturbed by cancer, these associated treatments (chemotherapy, radiotherapy and hematopoietic stem cell transplantation) but also undernutrition and the reduction in physical activity or even a sedentary lifestyle. Although the benefits of PA in oncology are now well identified for adult populations, studies are still rare in the population of children, adolescents and young adults, and the results are still difficult to generalize. As a result, there is no recommendation on the practice of physical activity in pediatric oncology or adolescents and young adults and the levels of physical activity of cured patients remain lower than those of the general population. Fitness is a marker of health in adults as well as in adolescents. Physical condition is a set of components such as cardiorespiratory capacity (transport and use of O2), body composition (distribution of bone, muscle and fat masses) and muscle function (strength, power, fatigue, energy metabolism) . The investigators hypothesize that, compared to young adults, recovered from lymphoma are expected to exhibit impaired physical condition, due to physical deconditioning.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 6, 2022
Est. primary completion date December 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Young adult male or female, aged 18 to 25 - giving free and informed consent - Hodgkin lymphoma or non-Hodgkin lymphoma in the healing stage - Cured (defined by an undetectable disease at the end of treatment) for at least one year and maximum 6 years of lymphoma or Hodgkin's disease Exclusion Criteria: - Legal incapable adults - People under judicial protection - Treatment with systemic glucocorticoids for more than a week, during the 30 days preceding the tests - Medical contraindication to the practice of physical exercise - Any pathologies (other than the history of lymphoma for the cases) likely to affect the metabolism or the muscle mass - Any treatment that may have an influence on the energy metabolism - Active infection - Pregnant, breastfeeding, or likely to be - Subject's refusal to participate

Study Design


Intervention

Other:
Indirect calorimetric test during submaximal exercise
metabolic evaluation by indirect calorimetry at rest and during exercise evaluation of cardiac output peripheral quantitative computed tomography (pQCT) of the muscle cross section evaluation of body composition assessment of physical capacity (chair test and 3 min step-test) blood test assess the level of physical activity

Locations

Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary fat oxidation rate maximum rate of lipid oxidation (in mg/ml) day at 11:30 am during one day
Secondary rest metabolism energy expenditure at rest in kcal. at 08:00 am in fasted condition during one day
Secondary blood insulinemia blood value of insulin in pmol/L at 07:30 am in fasted condition during one day
Secondary blood N-terminal pro-B natriuretic peptide blood N-terminal pro-B natriuretic peptide level in g/L at 07:30 am in fasted condition during one day
Secondary blood troponin blood troponin level in g/L at 07:30 am in fasted condition during one day
Secondary blood lipids blood lipids level in g/L at 07:30 am in fasted condition during one day
Secondary blood glucose blood glucose level in g/L at 07:30 am in fasted condition during one day
Secondary Body composition: fat percentage of fat at 07:30 am during one day
Secondary Body composition: lean mass percentage of lean mass at 07:30 am during one day
Secondary cardiac output Systolic Ejection Volume in mL evaluated at rest and during submaximal exercise at 11:30 am during one day
Secondary peripheral quantitative computed tomography Cross-sectional area of thigh muscles and intermuscular adipose tissue were assessed for muscle at 40% of the length between the greater trochanter and the mid-patella of the right leg at 10:45 am during one day
Secondary physical condition 3 min step-test (number of ascent / descent step) at 08:45 am during one day
Secondary physical capacity chair test (time in second held in position) at 08:45 am during one day
Secondary physical activity level daily energy expenditure (in Kcal) from day 2 to day 5
Secondary sedentary level total sedentary time (in min) evaluated by accelerometer for 4 days from day 2 to day 5
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