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A-CaRe study 1. Exercise after chemotherapy.

A-CaRe study 1. Resistance and Endurance exercise After ChemoTherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22359
Enrollment
400
Registered
2010-01-05
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

cancer survivors, physical exercise, chemotherapy, fatigue, physical fitness, quality of life, training, strength,

Interventions

1. High-intensity strength and endurance training
2. Herstel & Balans program
3. Waiting list control. Ad1. High intensity strength and endurance training. The 12-week training program consists of high-intensity strength and endurance training. The safety of the program is gu
2) leg press
3) bench press
4) pull over
5) abdominal crunch
6) lunge. Resistance exercises are performed at 65% to 80% of one-repetition maximum (1-RM) and consist of two sets of 10 repetitions. Every four weeks the training progress is evaluated, and the resu

Sponsors

EMGO Institute for Health and Care Research, VU medical Center Maxima Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological confirmed breast, colon, ovarian cancer or lymphomas with no indication of recurrent or progressive disease; 2. Age between 20 and 70 years; 3. Completion of (adjuvant) chemotherapy with curative intention and completion of surgival treatment or radiotherapy.

Exclusion criteria

Exclusion criteria: 1. Wheelchair dependent, or not able to perform basic activities like walking or cycling; 2. Contraindications for phsycial activity or exercise; 3. Serious psychiatric or cognitive problems or severe emotional instability; 4. Malnutrition; 5. Not familiar with the Dutch language; 6. Unable to follow exercise instructions; 7. Participating in concurrent studies or rehabilitation programs containing physical activity or exercise.

Design outcomes

Primary

MeasureTime frame
1. Cardiorespiratory fitness; 2. Muscle strength; 3. Fatigue. Ad1. Cardiorespiratory fitness is measured during a maximal exercise test on an electronically braked cycle ergometer according to a ramp protocol in which the resistance gradually increases every 6 seconds aiming to achieve a maximum within 8 to 12 minutes. Patients are instructed to cycle with a pedal frequency between 70 and 80 rpm, and are encouraged to continue exercising until exhaustion or inability to maintain the pedal frequency of 70 rpm. Expired gases are collected and analyzed breath by breath for O2, CO2, and volume. The average values of the last 30s of exercise are used as measure for peak oxygen consumption (peakVO2), peak power output, and peak heart rate. Ad2. Upper extremity muscle strength of adults is measured using a JAMAR grip strength dynamometer. Lower extremity muscle strength is tested by the functional 30s chair stand test, according to a standardized measurement protocol. Ad3. Two self-report questionnaires are used to assess fatigue: the Multidimensional Fatigue Inventory (MFI) and the Fatigue Quality List (FQL). The MFI consists of five subscales based on different dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. THE FQL consists of four subscales: frustrating, exhausting, pleasant, and frightening.

Secondary

MeasureTime frame
1. Body composition; 2. Health-Related Quality of Life; 3. Self-reported physical activity; 4. Mood disturbance; 5. Functioning in daily life; 6. Return to work. Ad1. Body height, body weight, waist and hip circumferences, and four skinfolds (biceps, triceps, suprailiac and subscapular) are assessed to estimate body composition. In addition, a dual-energy x-ray (DEXA) scan will be performed. Ad2. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer patients. The EORTC QLQ-C30 encompasses 30 items divided in five functional scales (physical, role, emotional, cognitive, social), three symptom scales (pain, fatigue, and emesis) and an overall QoL scale. Additional single items address other symptoms commonly experienced by cancer patients (e.g., insomnia, diarrhea, constipation, etc.). Ad3. To assess self-reported levels of physical activity, we will either use the Physical Activity Scale for Elderly (PASE) or the Activity Questionnaire for Adults and Adolescents (AQuAA), depending on the most valid and reliable questionnaire in cancer patients. At the moment, we are conducting a study to determine which of the two questionnaires had the best psychometric properties. Ad4. 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. Ad5. Functioning in daily life will be assessed with the Impact on Participation and Autonomy (IPA) Questionnaire.64 The IPA Questionnaire consists of 32 items assessing perceived level of participation and autonomy, organized into 5 domains: autonomy in the home, family role, autonomy outside of the home, social relations, and work and education. An additional 9 items assess perceived problems with participation and

Contacts

Public ContactLaurien Buffart

Van der Boechorststraat 7

l.buffart@vumc.nl+31 (0)20 4449931

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)