Ambulatory Physical Exercise Program in Hematopoietic Stem Cell Transplantation Recipients

Study Overview
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Brief Summary
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The proposed study in an inception cohort of patients with hematological malignancies treated with PBSCT is designed to evaluate the effects of a physical exercise intervention on muscular-skeletal, physical activity and quality of life outcomes.

Detailed Description
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Peripheral Stem Cell Transplantation is a frequently used therapy option to increase survival in hematological and lymphatic malignancies. These malignancies and their treatment are associated with numerous physical and psychological symptoms and severe side effects. Physical exercise has been proposed as a promising strategy for the treatment of some of these physical and psychological complaints, and various exercise interventions are currently available after cancer treatment. To date, promising preliminary results concerning exercise programs in PBSCT recipients were published with limited sample size populations. Results of musculoskeletal outcomes in PBSCT recipients after cancer treatment are lacking.

Official Title
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Physical Exercise to Improve Physical Performance and Health Related Quality of Life in Hematopoietic Stem Cell Transplantation Recipients

Conditions
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Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Behavioral: Ambulatory Physical Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Status after high-dose chemotherapy following Hematopoietic Stem Cell Transplantation Willing to enter a physical exercise program Good understanding of the German language Written informed consent Exclusion Criteria: Uncontrolled cardiovascular disease and myocardial infarction in the previous six months Uncontrolled hypertension Uncontrolled thyroid disease Uncontrolled diabetes Diagnosis of depression before entering the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Physical exercise group: Combined supervised physical activity: Endurance and Resistive strength | Behavioral: Ambulatory Physical Exercise Program<br>* supervised exercise, 2 x / week<br>|
| No Intervention: Group 2<br>Usual care control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Musculoskeletal performance |  | Baseline -3 months - 6 months | 
| Knee extension strength |  | Baseline -3 months - 6 months | 
| Grip Strength |  | Baseline -3 months - 6 months | 
| 6 minute walk test |  | Baseline -3 months - 6 months | 
| 15-meter walking speed |  | Baseline -3 months - 6 months | 
| and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire). |  | Baseline -3 months - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role-,cognitive-,emotional-,social-,symptom scales and the global health and quality of life scale of the EORTC-QLQ-C30 Health Related Quality of Life questionnaire. |  | Baseline -3 months - 6 months | 
| Self-reported fatigue |  | Baseline -3 months - 6 months | 
| Self-reported and objectively assessed physical activity |  | Baseline -3 months - 6 months | 
| Whole body composition |  | Baseline -3 months - 6 months | 
| Haemotological values: e.g Hemoglobin |  | Baseline -3 months - 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Exercise, Health Related Quality of Life, PBSCT