Effect of a structured exercise programme in improving outcome in terms of shoulder function after breast cancer surgery

Effect of STructured Exercise Program in improving functional morbidity and quality of life in Breast Cancer patients undergoing curative-intent surgery: A Randomized Controlled Trial (STEP-BC) - STEP-BC

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083738

Enrollment

128

Registered

2025-03-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Structured Exercise Programme: Pre operative work out. Immediate Post operative-walking b. relaxation c. Diaphragmatic breathing d. Ball squeezing e. Stretching And then gradual increa

Eligibility

Inclusion criteria

Inclusion criteria: 1. Eastern Clinical Oncology Group- Performance score (ECOG-PS): 0-2 2. Biopsy proven- non metastatic breast carcinoma 3. Undergoing surgery with curative intent.

Exclusion criteria

Exclusion criteria: 1.Second primary/ recurrent cancer. 2. Patients with severe comorbidities, distant metastasis 3.Patients already having shoulder disability due to preexisting shoulder joint pathology 4. Patient s current physical or mental condition not allowing to undergo a vigorous exercise programme 5. Patients not willing to participaTe

Design outcomes

Primary

Measure	Time frame
To assess whether the structured exercise program (SEP) improves the functional morbidity in the form of DASH (Disability of Arm, Hand, and Shoulder) score at 3 and 6 months among breast cancer patients undergoing curative-intent surgery.Timepoint: 3 and 6 months	—

Secondary

Measure	Time frame
1. To compare short- and long-term morbidity (wound related, pain, fatigue, lymphedema, etc. between two groups 2. To compare the change in long-term functional outcomes using the DASH score at 12 months 3. To compare the Health-Related Quality of Life outcomes measures (FACT B+4 & FACT-F score) between two groups. 4. To evaluate the effect of a structured exercise program in metabolic syndrome in the form of improvement in Metabolic Syndrome (MetS) z score at 6 monthsTimepoint: 6 months and 12 months	—

Measure

Time frame

1. To compare short- and long-term morbidity (wound related, pain, fatigue, lymphedema, etc. between two groups 2. To compare the change in long-term functional outcomes using the DASH score at 12 months 3. To compare the Health-Related Quality of Life outcomes measures (FACT B+4 & FACT-F score) between two groups. 4. To evaluate the effect of a structured exercise program in metabolic syndrome in the form of improvement in Metabolic Syndrome (MetS) z score at 6 monthsTimepoint: 6 months and 12 months

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Countries

India

Contacts

Public ContactDr Avisikta Mallick

AIIMS, Jodhpur

drjvishnoi@gmail.com8017999074

Outcome results

None listed

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