Efficacy of Seated Exercise on Functional Capacity and Quality of Life in Patients With Leukemia During Chemotherapy Cycles
Study Overview
Detailed Description
Cancer is a major public health that gives an economical burden on the patient and government. The incidence of different types of cell tumors are increasing nowadays. Although chemotherapy is given to kill cancer cells, it also damage normal cells and cause significant side effects while others may have more. Some CT side effects can be severe enough to require hospitalization effects. CT affects patients functional capacity and quality of life next to the cancer it self. This study is designed as randomized controlled trial to assess the impact of seated exercise on functional capacity and quality of life in patient with leukemia during chemotherapy cycles. participants will be recruited from Hematology unit, Department of General Internal Medicine, Benha University Hospitals .
The intervention protocol includes a-30 minutes seated exercise program three times a week with at least a one- day break between sessions for four weeks for the treatment group. Outcome measures will include maximum voluntary ventilation, 6 min walk test distance and FACT-G questionnaire before and after the exercise program. The program includes a five- minute warmup, 20 minutes of moderate-intensity repetitive motion exercise and a five- minute cool down.
Ethical considerations:
This study has been reviewed and approved by the Ethical Committee of Benha university. Written informed consent will be obtained from all participants or their legal guardians prior to treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male patients with age ranges from 30 to 40 years.
- All patients in this study will be on chemotherapy from at least one cycle as a treatment of leukemia.
- All patients will be hemodynamically stable.
- Patients are ambulant.
Exclusion Criteria:
- Lung cancer
- History of any pulmonary disease.
- Metastasis of lung , ribs and mediastinal structure.
- Pulmonary pathology (e.g. acute respiratory distress syndrome, or exacerbation of chronic obstructive pulmonary disease).
- Ruptured eardrum or any other condition of the ear.
- Severe bronchospasm.
- High peak air way pressure (barotraumas).
- patients with marked elevated left ventricular end- diastolic volume and pressure.
- patients with worsening haert failure signs and symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Seated exercise group
|
Participants in the intervention group will perform a structured seated exercise program during their chemotherapy cycles. The exercise program will consist of supervised, individualized seated exercises designed to improve functional capacity and quality of life. The exercise sessions will be performed according to the study protocol throughout the intervention period. Each session will consist of a five-minute warm up, 20 minutes of moderate intensity repetitive motion exercises, and a five -minute cool-down. Functional outcomes will be assessed before and after the exercise program. including maximum voluntary ventilation , six-minute walk test distance, and FACT- G quesionnaire. |
|
No Intervention: control group
control group will receive usual care/ standard advices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in functional capacity
Time Frame: Baseline and after 4 weeks of intervention
|
Functional capacity will be assessed by the six-minute walk test (6MWT) distance before and after the four week seated exercise programe.
|
Baseline and after 4 weeks of intervention
|
|
change in quality of life
Time Frame: Baseline and after 4 weeks of intervention
|
Quality of life will be assessed using the Functional Assessment of Cancer Therapy General (FACT-G) questionnaire before and after week seated exercise programe.
the total FACT-G score ranges from 0 to 108, with higher scores indicating better quality of life
|
Baseline and after 4 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Maximum Voluntary Ventilation (MVV)
Time Frame: Baseline and after 4 weeks of intervention
|
Change in Maximum Voluntary Ventilation (MVV) will be assessed before and after the four week seated exercise program
|
Baseline and after 4 weeks of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- seated exercises in leukemia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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