Skip to content

A-CaRe study 3: Exercise intervention after stem cell transplantation.

Physical exercise to improve fitness and combat fatigue in patients with multiple myeloma or (non-)Hodgkin's lymphoma treaded with high dose chemotherapy and autologous stem cell transplantation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25999
Enrollment
125
Registered
2010-05-27
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Physical exericse, Physical fitness, Fatigue, Stem cell transplantation

Interventions

Besides the standard care patients in the intervention arm follow an 18-weeks exercise. This program consists of high-intensity resistance and interval training. Before the start of the program, a spo
(2) leg press
(3) bench press
(4) pull over
(5) abdominal crunch
(6) lunge. Indirect one repetition maximum (1-RM) measurements will be performed every 4 weeks for all six exercises. In the first 12 weeks, the resistance exercise consists of two sets of 10 repetiti

Sponsors

Dept of Hematology, Academic Medical Center Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed with multiple myeloma in first line or with (non-)Hodgkin's lymphoma in first relapse and treatment with HDC and autologous SCT 6 to 12 weeks ago; 2. Age between 18 and 65 year; 3. Sufficiently recovered from the stem cell transplantation and having peripheral blood recovery; 4. Ability to cycle on a bicycle ergometer against a load of at least 25 watt; 5. Ability to walk at least 100 meters independently without crutches, canes or walking frame; 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Tandem autologous-allogenic stem cell transplantation; 2. Severe cognitive impairment; 3. Severe emotional instability; 4. Insufficient mastery of the Dutch language; 5. Presence of extensive osteolytic lesions with risk of fracture; 6. Serious cardiopulmonary and cardiovascular conditions; 7. Other disabling comorbidity interfering with the intervention program or influencing outcome parameters (a.o. having a pacemaker, epileptic seizures and poorly regulated diabetes mellitus); 8. Severe infections; 9. Relapse/progression of disease.

Design outcomes

Primary

MeasureTime frame
1. Cardiorespiratory fitness; 2. Muscle strength; 3. Fatigue. Ad 1) Cardiorespiratory fitness is measured during a VO2max test on a cycle ergometer under supervision of a sport physician. A ramp test design will be applied, after 4 minutes of unloaded cycling; the load will be gradually increased till exhaustion. Throughout the test ECG and pulse oxymetry will be monitored and heart rate, blood pressure and gas exchange variables will be measured. Among the variables that will be determined are the VO2peak, maximal heart rate, maximal work rate, maximal minute ventilation, VO2 uptake at ventilation threshold, and the maximal respiratory exchange ratio. Ad 2) Upper extremity muscle strength of adults is measured using a grip strength dynamometer. Lower extremity muscle strength is tested by the functional 30s chair stand test, according to a standardized measurement protocol. Ad 3) Two self-report questionnaires will be used to assess fatigue: the Multidimensional Fatigue Inventory (MFI) and the Fatigue Quality List (FQL). The MFI consists of 5 subscales based on different dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. The FQL consists of 25 adjectives describing the fatigue experience, organized into 4 subscales: frustrating, exhaustion, pleasant and frightening.

Secondary

MeasureTime frame
1. Body composition and bone mineral density; 2. health-related quality of life; 3. Physical activity level; 4. Mood disturbance; 5. Functioning in daily life; 6. Return to work; 7. Satisfaction with the intervention. Ad 1) Body composition and bone mineral density will be measured using dual-energy-x-ray (DXA). Body composition will also be estimated with the use of antrometry data. Ad 2) Health-related quality of life will be determined with the EORTC Core Quality of Life Questionnaire C30 (QLQ-C30), the EORTC myeloma module (QLQ-MY20; only for patients with multiple myeloma) and the ZLZ-CIPN20 questionnaire. The EORTC QLQ-C30 encompasses 30 items divided in five functional scales, three symptom scales and an overall QoL scale. Additional single items address other symptoms commonly experienced by cancer patients. The QLQ-MY20 is used to receive extra information on the HR-QoL in patients with multiple myeloma. Chemotherapy induced peripheral neuropathy will be scored using the ZLZ-CIPN20 questionnaire. Ad 3) Physical activity is measured with the PASE Questionnaire. In addition, physical activity is measured by the Actitrainer accelerometer, Ad 4) Mood disturbance will be assessed with the 14-item Hospital Anxiety and Depression Scale (HADS). The HADS assesses symptoms of mood disturbance, yielding separate scale scores for anxiety and depression, as well as a total score. Ad 5) Functioning in daily life will be assessed with the Impact on Participation and Autonomy (IPA) questionnaire. The IPA questionnaire consists of 32 items assessing perceived level of participation and autonomy, organised into 5 domains. Ad 6) The following indices of RTW are measured: 1. time to partial and full return RTW; 2. time to full RTW corrected for partial RTW; 3. Partial and full RTW rate at follow up; 4. Details on hours worked per week, nature of the work, and return to a different job will also be recorded. Ad 7) Satisfaction with the intervention is assesse

Contacts

Public ContactS. Persoon

Meibergdreef 9, A01.386

S.Persoon@amc.uva.nl+31 (0)20 5668387

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)