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Clinical Trials/NCT04257643
NCT04257643CompletedNot Applicable

Efficacy of Aquatic Based Versus Land-based Exercise in Lymph Edema Post-mastectomy: a Prospective Randomized Controlled Trial.

Cairo University2 sites in 1 country50 target enrollmentStarted: July 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
2
Primary Endpoint
Limb volume measurement:

Study Overview

Brief Summary

Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Intervention group received 60 minutes aquatic-based exercise in the form of warm-up for 10 mins, then strengthening exercise for 40 minutes, followed by 10 min cooling down in the form of stretching and mobility exercise, three times a week for 8 weeks, plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. The control group received 60 minutes of land base exercise, three times a week, for 8 weeks. Arm volume, shoulder flexion, abduction range of motion and pain using a visual analogue scale were assessed at baseline and after 8 weeks of treatment.

Detailed Description

Group A: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in Group-A had been dealt with water-based exercise was conducted at a hydrotherapy pool for the Eden Health care, cairo, The pool measures 8 × 15 m and ranges from 1 to 1.8 m in depth with access via steps. Interventions were conducted predominately in the deeper section of the pool so participants immerse their neck in water.

Control group, Group B: 25 female Patients there aged ranged from 37 to 67 years old with BCRL, in control group had been dealt Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Breast cancer with unilateral axillary lymph node excision.
  • Mild-moderate degreed lymphedema (stage I and II) .
  • Lymphedema with a duration of at least 1 year .

Exclusion Criteria

  • Recurrence of cancer.
  • Ongoing active oncological treatment.
  • Functional disorders hindering participation in exercise programs.
  • Open wound at any area of the body.

Outcomes

Primary Outcomes

Limb volume measurement:

Time Frame: 8 weeks.

the patient in a comfortable sitting position, a standard one cm, retractable, the fibreglass tape measure was used to perform circumference measurement. The measurement was made at, 10, 20, 30, and 40 cm above the ulnar styloid process,

Secondary Outcomes

  • Range of Motion(8 weeks.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hadaya Mosaad

Principal investigator.

Cairo University

Study Sites (2)

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