Aquatic Versus Land Based Exercise on Lymphedema Post Mastectomy

NCT ID: NCT04257643

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-11-30

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 .

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

aquatic based exercise.

Intervention Type: OTHER

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

land-based exercise.

Intervention Type: OTHER

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 .

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

Group Type: ACTIVE_COMPARATOR

land-based exercise.

Intervention Type: OTHER

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 .

Interventions

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

Intervention Type: 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 .

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hadaya Mosaad

Principal investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khadra M Ali, Phd

Role: PRINCIPAL_INVESTIGATOR

Cairo University, Faculty of physical Therapy.

Locations

Cairo university.

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002615

Identifier Type: -

Identifier Source: org_study_id