Effect of exercise on bone health for arm swelling after breast cancer

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2023/01/048813
• Lead Sponsor: Manipal Academy of Higher Education

Brief Summary

This single arm, single centered quasi experimental study will study the effects of resistance exercises for 12 weeks on the bone mineral density, limb girth and upper limb function in breast cancer patients or breast cancer survivors diagnosed with breast cancer related lymphedema. The outcomes will be assessed pre and post intervention (exercise training program).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-01
• Study Start: 2023-10-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Breast cancer survivors with upper limb lymphedema after: 1.
• breast conservative surgery 2.
• modified radical mastectomy with axillary node dissection (levels I and II), 3.
• adjuvant chemotherapy and radiotherapy and hormonal therapy.

Exclusion Criteria

• Participants unable to follow instructions 1.
• Musculoskeletal disorders (rheumatoid arthritis, fragility fractures involving upper limb, compartment syndrome) in which exercises cannot be performed.
• Clinical evidence of impaired peripheral vascular circulation in affected limb with BCRL 3.
• Clinical evidence of acute cellulitis in affected limb with BCRL 4.
• End stage organ failure (renal, cardiac, hepatic) 5.
• Left ventricular ejection fraction < 25% with s/o congestive cardiac failure 6.
• Severe valvular heart disease 7.
• Participants with any acute illness 8.
• Bilateral upper limb lymphedema 10.
• Participants receiving pharmacological treatment for osteoporosis and bone health 11.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density (T-score)	Time point 1 - Day 0 (Baseline) | Time point 2 - Day 90 (Post Intervention)

Secondary Outcome Measures

Name	Time	Method
Limb Girth (ml)	Upper Limb function

Trial Locations

Locations (1)

Kasturba Hospital, Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital, Manipal

🇮🇳Udupi, KARNATAKA, India

Nivedita S Prabhu

Principal investigator

9901729546

nivedita.kamath@manipal.edu