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Physical exercise prior to hematopoietic stem cell transplantation

Physical exercise prior to hematopoietic stem cell transplantation: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30955874
Enrollment
30
Registered
2013-08-16
Start date
2011-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with acute or chronic leukemia, Hodgkin?s Lymphoma, non-Hodgkins?s Lymphoma or Multiple Myeloma, and scheduled to undergo an allogenic or autologous HSCT Cancer

Interventions

The participants were allocated to the groups based on the postal code of their home address. Participants living in the proximity if the University Medical Centre were allocated to the intervention g
6 weeks prior to HSCT), 6 weeks (T1
before HSCT) and at 6 weeks (T2) and 3 months after HSCT (T3).

Sponsors

Scientific Institute for Quality of Healthcare (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In order to be selected they need to meet the following inclusion criteria: 1. Diagnosed with acute or chronic leukemia, Hodgkin?s Lymphoma, non-Hodgkins?s Lymphoma or Multiple Myeloma 2. Scheduled to undergo an allogenic or autologous HSCT 3. Sufficient knowledge of the Dutch language 4. Approval to participate in the study by the treating physician, and 5. Being aged in the age range 18 years through 65 years, either sex

Exclusion criteria

Exclusion criteria: 1. Cardiovascular or other contra-indications (e.g. rheumatic disease) for participating in a physical exercise program. Decisions to exclude potential participants will be made based on the results of the Physical Activity Readiness Questionnaire (PAR-Q) and after consultation with the physician.

Design outcomes

Primary

MeasureTime frame
1. For the primary outcomes self-perceived physical functioning and QOL, patients fill out the Short Form Health Survey (SF-36). With the SF-36, 36 questions are answered to score perceived health related to quality of life (QOL). With this questionnaire 36 questions are grouped into eight domains of which our primary outcome ?self-perceived physical functioning? is one domain. All scores in the SF-36 range from 0-100 points (higher scores are related to better outcome). For QOL, a physical component score (PCS) and a mental component score (MCS) can be derived from the total SF-36 score. 2. With the Checklist Individual Strength (CIS) the primary score for severity in fatigue was evaluated. The questionnaire consists of four domains, of which ?Severity of Fatigue? is one domain. The total CIS score (ranging from 20-140 points) and the score of ?Severity of Fatigue? (ranging from 8-56 points) are evaluated in this study.

Secondary

MeasureTime frame
1. Physical fitness The maximum oxygen uptake (peak VO2) is estimated by means of the Åstrandtest. The Åstrandtest is a submaximal 6-minute bicycle test for the aerobic endurance capacity. During the test the cadence has to be 50 to 60 rpm with a Wattage of 75, 100, 125 or 150. The Wattage is estimated by the researcher based on habitual physical activity and fitness level of the participant and can be increased or decreased during the first 2 minutes of the test. After 2 minutes cycling at 60 rpm the participant?s heart rate should rise to 130 ? 160 bpm and reach a steady state. The heart rates of minute 5 and 6 of the test will be recorded. With the average heart rate of minute 5 and 6, gender, weight and wattage the VO2 max can be estimated. 2. Global perceived recovery The global perceived recovery score is used to measure the patients? opinion about the effect of the intervention on a 7-point Likert scale ranging from very much deterioration to very much improvement 3. Muscle Strength The muscle strength of the large muscle groups is monitored with the handgrip dynamometer (JAMAR) and the MicroFET2 (Biometrics Europe BV, Almere, Netherlands). For the handgrip both hands separately apply as much grip pressure as possible on the dynamometer. The MicroFET hand-held dynamometer is used to measure muscle strength of the arm flexors and leg extensors bilaterally on all subjects conform manual. The break test is used which means that the subject is asked to exert a maximum force against the applicator, and the rater rapidly applies a countering force to overcome the subject?s exertion. All measurements are performed bilaterally three times and the highest score is used in the analysis. 4. Infections The amount of leukocytes and trombocytes. Leukocytes and thrombocytes counts are routinely and regularly sampled during the outpatient visit or in the clinic and registered in patient files. 5. Length of stay Total length of hospital stay was registered by means

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026