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Clinical Trials/NCT00554489
NCT00554489
Completed
N/A

A Feasibility Study of a Physical Activity Intervention in Older Adult Inpatients With Acute Leukemia

Wake Forest University Health Sciences1 site in 1 country26 target enrollmentJuly 2007
ConditionsLeukemia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Leukemia
Sponsor
Wake Forest University Health Sciences
Enrollment
26
Locations
1
Primary Endpoint
Percentage of eligible patients recruited into the study
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

RATIONALE: Physical activity sessions may help improve physical function, quality of life, and symptoms caused by chemotherapy in older patients with acute myelogenous leukemia.

PURPOSE: This clinical trial is studying how well physical activity works in improving quality of life in older patients with acute myelogenous leukemia undergoing chemotherapy.

Detailed Description

OBJECTIVES: Primary * To test the feasibility of conducting a physical activity intervention in hospitalized older adults with acute myeloid leukemia (AML) undergoing induction or reinduction chemotherapy. Secondary * To obtain preliminary data regarding the effectiveness of a physical activity intervention on physical function, quality of life, and treatment-related symptoms in these patients. OUTLINE: Patients undergo a baseline evaluation in week 1 focusing on basic demographics, health, physical function and quality-of-life assessments. These assessments include the Short Physical Performance Battery (SPPB); the Hand Grip Test of Muscular Strength; the Demographics and Physical Activity History; the Functional Assessment of Cancer Therapy (FACT-Leu); the Distress Thermometer; the Short-form Positive Affect Schedule (PANAS-SF); the Satisfaction with Life Scale (SWL); the FAST-23 Disability Measure; the Center for Epidemiologic Studies Depression Scale Short Form (CES-D); the Self-efficacy for Physical Activity Scale; the Intervention Feedback Form; and the Pre-Post Session Ratings. Some medical data may be obtained from the patient's medical record to assist in these assessments. Beginning in weeks 2-5, patients undergo a 30-minute orientation to the exercise sessions that will be tailored to individual needs and abilities. Patients undergo a 30- to 45-minute group physical activity session twice a week, and a supervised individual session following the same format as the group session, once a week for 4 weeks. After completion of the physical activity intervention, patients complete an activities packet and repeat the physical function and quality of life assessments in weeks 5-6 and again upon readmission for consolidation therapy in weeks 9-13 . After completion of study intervention, patients are followed for 4 months.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
April 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of eligible patients recruited into the study

Time Frame: day 1

Percentage of study participants who successfully completed the physical and the psychosocial measures

Time Frame: week 13

Number and frequency of reported barriers to eligibility and enrollment

Time Frame: day 1

Percentage of adults 50 years of age or older admitted for induction or reinduction chemotherapy for acute myeloid leukemia (AML) who are eligible for the study

Time Frame: day 1

Record barriers to completion of the physical activity program

Time Frame: week 13

Secondary Outcomes

  • Physical function as measured by the Short Physical Performance Battery (SPPB)(week 13)
  • Quality of Life as measured with the Distress Thermometer(week 13)

Study Sites (1)

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