EXIST: Physical exercise to improve fitness and combat fatigue in patients with Multiple Myeloma or (non-) Hodgkin*s lymphoma after high dose chemotherapy and autologous stem cell transplantation.
- Conditions
- (Non-)Hodgkins lymphomamultiple myeloma10025319
- Registration Number
- NL-OMON36504
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 125
-diagnosed with multiple myeloma in first line or or with HL/NHL in first line or first relapse, who have undergone HDC and autologous SCT 6 to 12 weeks ago or who where recently (< 8 months) treated with HDC and autologous SCT and who have completed radiotherapy or their last cycle of consolidation chemotherapy 2 to 6 weeks ago-Sufficiently recovered from the SCT and having peripheral blood recovery;
-Age between 18 and 65 years;
-Ability to cycle on a bicycle ergometer against a load of at least 25 Watt;
-Ability to walk at least 100 meters independently without crutches/cains or walking frame;
-Written informed consent.
-tandem autologous-allogeneic stem cell transplantation
-Severe cognitive impairment;
-Severe emotional instability;
-Insufficient mastery of the Dutch language;
-Presence of extensive osteolytic lesions with risk of fracture;
-Serious cardiopulmonary and cardiovascular conditions;
-Other disabling comorbidity interfering with the intervention program or influencing outcome parameters (a.o. having a pacemaker , epileptic seizures and poorly regulated diabetes mellitus);
-Severe infections;
-Relapse/progression of disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>primary outcome variables are fatigue, cardiorespiratory fitness and muscle<br /><br>strength.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome variables include body composition and bone mineral density,<br /><br>health-related quality of life, physical activity level, satisfaction with the<br /><br>intervention, mood disturbances, functioning in daily life and return to work. </p><br>