Clinical trial NCT04406285: Effects of Periodized and Autoregulated Resistance Training in Haematological Cancer Patients During the Treatent.
Official title: Effects of Periodized and Autoregulated Resistance Training Programs in Haematological Cancer Patients Undergoing High-dose Chemotherapy and Hematopoietic Stem Cell Transplantation: A Randomized, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Leukemia
Lymphoma
Physical Disability
Keywords: Fatigue
Physical Therapy
Hematological Malignancy
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be included sequentially by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by Random Allocation System software in two separate lists: one for patients diagnosed with leukemia (subdivided into a control and experimental group) and other for patients diagnosed with lymphoma (equally divided into a control and experimental group). The allocation ratio will be 1/1 in order to maintain balance in division between control and experimental groups. On the other hand, balancing the different clinical diagnoses will depend on chance, even though the historical average of the service shows similar proportions in the number of cases treated.
Primary purpose: TREATMENT

Brief summary: Several clinical trials have demonstrated the positive impact of physical functioning and fatigue in patients who received training programs during the myeloablative chemotherapy with stem cell transplantation. However, the heterogeneity among the forms of physical activity results in moderate to very low evidence available about benefits of physical exercise. In this randomized and controlled clinical trial, we will study the effects on physical performance and fatigue of periodic resistance training programs, with an autoregulated approach within a non-linear model, based on the individual patient response to cancer treatment.

Detailed description: The sample will consist of 66 patients diagnosed with leukemia and lymphoma undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation, who will be randomized into two groups. The physical performance and fatigue outcomes will be compared between the control and the experimental group. The control group will perform an exercise program based on the standard protocol of physical therapy, consisting of bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient's feedback (from 70% of maximum heart rate) and resistance exercises for muscle groups hip flexors, knee extensors and ankle plantar flexors and resistance training form arms, with weigths of 0,5 to 1,0 kg (10 repetitions, 1 set).

The experimental group will perform a periodic resistance training program, with an auto-regulated and a non-linear model, using the Submaximal Ergometer tests with incremental load (from 85% of maximaum heart rate or maximum effort related), 30-Second Chair Stand, Hand Grip strenght and submaximal effort of arms with weights of 0,5 to 1,0 kg.

Eligibility criteria: Inclusion Criteria:

* Patients clinically diagnosed with Leukemia or Lymphoma, in the first or second line of treatment, undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation;
* Neurological and cognitive functions preserved;
* Physical conditions that enable participation in physical rehabilitation.

Exclusion Criteria:

* Clinical Complications that contraindicate physical therapy exercises, including the practice of cycle ergometer and resistance exercises;
* Previous musculoskeletal alteration that interferes in physical performance evaluation tests;
* Recent cardiovascular or pulmonary disease;
* Psychiatric or neurological disorder;
* Inability to walk on its own or presence of bone metastasis;
* Adherence on less than 50% of the total sessions of the study.

Primary outcomes:
measure: Fatigue
timeFrame: Trough study completion, an average of 17 months
measure: Physical Functioning Maximum Capacity
timeFrame: Trough study completion, an average of 17 months
measure: Lower Limb Physical Functioning and Strength
timeFrame: Trough study completion, an average of 17 months
measure: Handgrip Strength Physical Functioning
timeFrame: Trough study completion, an average of 17 months
Secondary outcomes:
measure: Healt-related quality of life: EORTC QLQ-C30
timeFrame: Trough study completion, an average of 17 months
measure: Symptoms Assessment
timeFrame: Trough study completion, an average of 17 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Fabrício Edler Macagnan
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
References: