Clinical trial NCT04257643: Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy
Official title: Efficacy of Aquatic Based Versus Land-based Exercise in Lymph Edema Post-mastectomy: a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Aquatic exercise-
Land based exercise
lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Limb volume measurement:
timeFrame: 8 weeks.
Secondary outcomes:
measure: Range of Motion
timeFrame: 8 weeks.
Other outcomes:
measure: Visual analogue scale for pain assessment
timeFrame: 8 weeks.
Locations:
city: Cairo.
country: Egypt
facility: Cairo university.
state: Cairo
Study officials:
affiliation: Cairo University, Faculty of physical Therapy.
name: Khadra M Ali, Phd
role: PRINCIPAL_INVESTIGATOR
References: