Effects of Periodized and Autoregulated Resistance Training in Haematological Cancer Patients During the Treatent.

NCT04406285 | Unknown DMC

• 1 other identifier: TMO-2019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Fatigue; Leukemia; Lymphoma; Physical Disability

Keywords

Fatigue; Physical Therapy; Hematological Malignancy

Outcome Measures

Primary Outcomes (4)

• Fatigue

  Piper Fatigue Scale, developed by Piper et al. (1998), is a multidimensional measure of fatigue in the field of cancer research and includes subdomains of the behavioral, affective, sensorial and cognitive attributes / fatigue mood, composed of 22 items. The scores for each item range from 0 to 10 and can total 220 points. Higher values characterize a greater perception of fatigue. It will be applied on patient's evaluation day and on hospital discharge day.

  Trough study completion, an average of 17 months

• Physical Functioning Maximum Capacity

  To evaluate the maximum capacity and endurance of the participants of this study, based on the concept of periodization (volume, intensity and frequency) and self-regulation (volume, intensity and magnitude according to daily readiness of the patient), by Fairman et al., (2017), the patient will perform a submaximal incremental exercise test in a cycle ergometer with electromagnetic braking, keeping the cadence fixed throughout the whole period of the test; the workload will be adjusted progressively every 1 minute until it reaches 85% of maximum heart rate or until the patient reports fatigue. At each load increase, the evaluation of the perceived effort will be performed through the BORG scale. The load, time and distance variables will be evaluated daily.

  Trough study completion, an average of 17 months

• Lower Limb Physical Functioning and Strength

  The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average.

  Trough study completion, an average of 17 months

• Handgrip Strength Physical Functioning

  A standard adjustable-handle hydraulic dynamometer will be used to measure hand grip strength as an index of upper limb strength. The Jamar® dynamometer, developed by Bechtol (1954), is considered the most accepted instrument ("gold standard") and is recommended by the American Society of Hand Therapists (ASHT) for being simple, to enable a quick and direct reading of the data and to enable its use in different fields of research. Three measurements of the manual grip strength should be performed in both hands, considering that the maximum difference between them does not exceed 10%, and the average of these being considered as the maximum value.

  Trough study completion, an average of 17 months

Secondary Outcomes (2)

• Healt-related quality of life: EORTC QLQ-C30

  Trough study completion, an average of 17 months

• Symptoms Assessment

  Trough study completion, an average of 17 months

Study Arms (4)

Leukemia Control Group

ACTIVE COMPARATOR

In this group the exercise program will be based on the standard protocol of physical therapy.

Other: Standard protocol Leukemia

Leukemia Experimental Group

EXPERIMENTAL

In this group the exercise program will be based on a periodic resistance training program, with an autoregulated approach within a non-linear model, based on the individual's patient daily response.

Other: Periodic Resistance Training Program Leukemia

Lymphoma Control Group

ACTIVE COMPARATOR

In this group the exercise program will be based on the standard protocol of physical therapy.

Other: Standard protocol Lymphoma

Lymphoma Experimental Group

EXPERIMENTAL

In this group the exercise program will be based on a periodic resistance training program, with an autoregulated approach within a non-linear model, based on the individual's patient daily response.

Other: Periodic Resistance Training Program Lymphoma

Interventions

Standard protocol Leukemia OTHER

* Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate); * Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets); * Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets).

Leukemia Control Group

Periodic Resistance Training Program Leukemia OTHER

* Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related); * 30-Second Chair Stand; * Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels.

Leukemia Experimental Group

Standard protocol Lymphoma OTHER

* Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate); * Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets); * Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets).

Lymphoma Control Group

Periodic Resistance Training Program Lymphoma OTHER

* Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related); * 30-Second Chair Stand; * Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels.

Lymphoma Experimental Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (2)

Fabrício Edler Macagnan

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Fatigue; Leukemia; Lymphoma; Hematologic Neoplasms

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 28, 2020
• Study Start: June 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2021
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)