Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: aquatic based exercise.; Other: land-based exercise.

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Cairo., Cairo, Egypt, 0025
      • Cairo university.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; water-based exercise was conducted at a hydrotherapy pool for the Eden Heelth 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. Thermo neutral water temperature, 30-32 °C at room temperature. Females were instructed to adjust water depth completely covering clavicles from standing position. Diaphragmatic breathing during exercise routine to assist with lymph fluid clearance. Exercise continuously for 40 to 45 min Full-body warm-up exercise for 10 min and cooling down for 10 minutes. Plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.	Other: aquatic based exercise.; exercise under water with the patient standing in a swimming pool, for 60 minswith water to the neck and then practice the arm exercise plus the diaphragmatic breathing exercise. The duration of the exercise programs was selected to be 60 minutes, 3 days per week for 8-week intervention; Other: land-based exercise.; land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.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 [14]. Women were asked to exercise continuously for 60 mins, by performing the arm exercises by repeating the session, and were instructed to exercise at moderate intensity .
Active Comparator: Control group; 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	Other: land-based exercise.; land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.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 [14]. Women were asked to exercise continuously for 60 mins, by performing the arm exercises by repeating the session, and were instructed to exercise at moderate intensity .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb volume measurement:	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,	8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Upper extremity active ROM for shoulder flexion and abduction were assessed in the standing position using a standard goniometric method	8 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale for pain assessment	horizontal (HVAS) or vertical (VVAS) line, usually 10 centimetres (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, the time period for reporting, and verbal descriptor anchors have varied widely in the literature depending on the intended use of the scale	8 weeks.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Khadra M Ali, Phd, Cairo University, Faculty of physical Therapy.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: lymphedema; Aquatic exercise-; Land based exercise
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: P.T.REC/012/002615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: We will share results after 6 months from publication.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No