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Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy

NCT ID: NCT02105389

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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Cancer-related fatigue (CRF) is a major problem in children, adolescents and adults receiving treatment for cancer, and intensively treated patients may be at higher risk. While exercise is an effective intervention for CRF, patients receiving the most intensive chemotherapy may frequently be too ill to participate in a standardized exercise program. A unique intervention that combines exercise and relaxation is yoga. This pilot study will evaluate the feasibility of three times weekly yoga sessions administered by a trained yoga instructor for a three week duration and will enroll between 10 and 20 children. If feasible, the intervention will be tested in a randomized controlled trial.

Detailed Description

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Conditions

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Fatigue

Keywords

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fatigue quality of life chemotherapy haematopoietic stem cell transplantation children pilot yoga

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Individualized Yoga Intervention

Individualized Yoga Intervention sessions will be administered by a trained yoga instructor three times weekly (or up to a maximum of five times per week) for three consecutive weeks. There will be a common structure for all sessions that will include relaxation and breathing exercises as well as a series of poses focused on strengthening, flexibility, and balance. There will be low, moderate and high intensity regimens prescribed depending on the wishes and abilities of the child and parent and the judgment of the yoga instructor.

Group Type EXPERIMENTAL

Individualized Yoga Intervention

Intervention Type BEHAVIORAL

Interventions

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Individualized Yoga Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with any acute myeloid leukemia (AML), relapsed acute lymphoblastic leukemia, stage 3 or 4 Burkitt's lymphoma/leukemia or about to receive autologous or allogeneic haematopoietic stem cell transplantation (HSCT)
* Expected to be an inpatient for at least three weeks after initiation of chemotherapy or conditioning
* Ages 7 to 18 years of age at enrollment

Exclusion Criteria

* Features present to an extent that would preclude compliance with yoga (as assessed by the attending physician): a) motor disability, b) cognitive disability, c) cardiopulmonary symptoms, or d) known compression fracture resulting in disability
* Parent or patient cannot understand English
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Lillian Sung

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Diorio C, Schechter T, Lee M, O'Sullivan C, Hesser T, Tomlinson D, Piscione J, Armstrong C, Tomlinson G, Sung L. A pilot study to evaluate the feasibility of individualized yoga for inpatient children receiving intensive chemotherapy. BMC Complement Altern Med. 2015 Jan 24;15:2. doi: 10.1186/s12906-015-0529-3.

Reference Type DERIVED
PMID: 25617154 (View on PubMed)

Other Identifiers

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Yoga Pilot

Identifier Type: -

Identifier Source: org_study_id