A trial for detecting and promoting physical activity for sedentary patients with breast cancer undergoing adjuvant chemotherapy

A randomized controlled trial for detecting and promoting physical activity for sedentary patients with breast cancer undergoing adjuvant chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13816000

Enrollment

154

Registered

2014-03-13

Start date

2013-12-15

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Breast cancer receiving adjuvant chemotherapy Cancer Malignant neoplasm of breast

Interventions

All study group participants are encouraged to meet the national recommendations for physical activity by their treating oncologist/nurse. Both groups receive individual motivational counseling to sup

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with breast cancer (stage I - III) in adjuvant chemotherapy 2. WHO performance status of 0 or 1 3. Aged 18 + years who do not meet criteria for recommended physical activity levels of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.

Exclusion criteria

Exclusion criteria: 1. Patients with myocardial infarction within the past three months 2. Symptomatic heart failure or contraindication for moderate to strenuous physical activity noted in the medical records.

Design outcomes

Primary

Measure	Time frame
Maximum oxygen uptake - VO2-peak (Measured baseline and at 6, 12 and 39 weeks).	—

Secondary

Measure	Time frame
1. Dual Energy X-ray Absorptiometry scan (baseline and 12, 39 weeks) 2. Muscular strength (baseline and at 6, 12 and 39 weeks) 3. Blood cholesterols (baseline, 12 and 39 weeks) 4. Blood pressure, pulse 5. Body mass index 6. Performance status (baseline and 6, 12 and 39 weeks) 7. Self-reported physical activity, Quality of Life (EORTC QLQ C-30) 8. General Wellbeing (SF 36) 9. Anxiety and Depression (HADs) 10. Motivational readiness 11. Decisional balance, Exercise self-efficacy, social support, (baseline and at 6, 12 and 39 weeks) 12. Labor market affiliation (baseline and at 12 and 39 weeks) 13. Cardiovascular comorbidity, disease free survival and recurrence. The following two outcome measures were added to this record on 17/02/2015: 14. Bioimpedance spectroscopy 15. Subjective assessments of symptoms related to lymphedema using VAS	—

Measure

Time frame

1. Dual Energy X-ray Absorptiometry scan (baseline and 12, 39 weeks) 2. Muscular strength (baseline and at 6, 12 and 39 weeks) 3. Blood cholesterols (baseline, 12 and 39 weeks) 4. Blood pressure, pulse 5. Body mass index 6. Performance status (baseline and 6, 12 and 39 weeks) 7. Self-reported physical activity, Quality of Life (EORTC QLQ C-30) 8. General Wellbeing (SF 36) 9. Anxiety and Depression (HADs) 10. Motivational readiness 11. Decisional balance, Exercise self-efficacy, social support, (baseline and at 6, 12 and 39 weeks) 12. Labor market affiliation (baseline and at 12 and 39 weeks) 13. Cardiovascular comorbidity, disease free survival and recurrence. The following two outcome measures were added to this record on 17/02/2015: 14. Bioimpedance spectroscopy 15. Subjective assessments of symptoms related to lymphedema using VAS

—

Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026