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Exercise as Intervention in Chronic Lymphocytic Leukemia - Trial NCT06396611

Access comprehensive clinical trial information for NCT06396611 through Pure Global AI's free database. This phase not specified trial is sponsored by Universidade do Porto and is currently Recruiting. The study focuses on Chronic Lymphocytic Leukemia. Target enrollment is 40 participants.

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NCT06396611
Recruiting
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06396611
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Exercise as Intervention in Chronic Lymphocytic Leukemia
Randomised Controlled Clinical Trial of Exercise as Intervention in Chronic Lymphocytic Leukemia

Study Focus

Exercise Training as Intervention

Interventional

behavioral

Sponsor & Location

Universidade do Porto

Porto, Portugal

Timeline & Enrollment

N/A

Sep 01, 2023

Aug 31, 2025

40 participants

Primary Outcome

Change in VO2 peak as measured by cardiopulmonary exercise test,Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test,Change in muscular strength (grip force in kg) as measured by dynamometer exercise test,Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test,Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass),Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)

Summary

PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise
 training, as measured by aerobic capacity, strength and physical function, and body
 composition, in patients with Chronic Lymphocytic Leukemia (CLL).
 
 DESIGN: Subjects will have confirmed treatment naรฏve CLL. Subjects will be assigned to either
 a 16-week control group (no supervised exercise) or an intervention group of Resistance
 Training (REx). Before and after the 16-week protocol, patients will undergo several tests
 including: 1) a maximal cycle ergometer test, 2) Body Composition, 3) Muscle strength, 4)
 physical activity levels, 5) blood measures (e.g. immune and inflammatory functions).
 
 DATA ANALYSES & SAFETY ISSUES: For outcomes, group change differences from baseline to
 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality
 already studied in other cancer patients. The regular use of vigorous-intensity exercise has
 been used extensively in exercise training. It will always be respected for each subject's
 safety tolerance while challenging.
 
 HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise
 interventions for people with CLL and will improve health and fitness markers.

ICD-10 Classifications

Chronic lymphocytic leukaemia of B-cell type
Chronic myelomonocytic leukaemia
Acute myelomonocytic leukaemia
Lymphoid leukaemia
Chronic leukaemia of unspecified cell type

Data Source

ClinicalTrials.gov

NCT06396611

Non-Device Trial