Effectiveness of Home-based Exercise in Quality of Life and Physical Fitness in Older Woman in Breast Cancer Treatment

NCT02408133 | Completed

• 1 other identifier: U1111-1165-5043
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of home exercise on quality of life and physical fitness of elderly women with breast cancer patients undergoing cancer treatment.

Conditions

Breast Cancer

Keywords

Breast Cancer; elderly; quality of life; exercise

Outcome Measures

Primary Outcomes (9)

• Variation in the performance of Lift and Sitting Test

  Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the Lower body strength according to the number of times the individual stood up and sat down in 30 seconds. Characterized as continuous numeric variable.

  Change from Baseline in Lift and Sitting Test and after 12 weeks

• Variation in the performance of Flexion forearm Test

  Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the upper body strength according to the number of push-ups of forearm in 30 seconds. Characterized as continuous numeric variable.

  Change from Baseline in Flexion forearm Test and after 12 weeks

• Variation in the performance of Six Minute Walk Test (6MWT)

  Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance. Total meters walked for 6 minutes walk. Characterized as continuous numeric variable.

  Change from Baseline in Six Minute Walk Test (6MWT) and after 12 weeks

• Variation in the performance of March Stationary two minutes Test

  Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance (alternative test). Total double past stationary in 2 minutes. Characterized as continuous numeric variable.

  Change from Baseline in March Stationary two minutes Test and after 12 weeks

• Variation in the performance of Skip and Vir 2.44 meters test

  Test which comprises the Battery Senior Fitness Test (SFT). Assesses motor agility and dynamic balance. Evaluates the time in seconds and hundredths in an established path of 2.44 meters on the route to go and return to starting position. Characterized as continuous numerical variable.

  Change from Baseline in Skip and Vir 2.44 meters test and after 12 weeks

• Variation in the performance of Sit and Reach Modified test (In the Chair)

  Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the lower hemisphere flexibility. distance in centimeters reached the tip of the middle fingers and the floor in the sitting position. Characterized as continuous numerical variable.

  Change from Baseline in Sit and Reach Modified test (In the Chair) and after 12 weeks

• Variation in the performance of Flexibility test of the upper limbs

  Test which comprises the Battery Senior Fitness Test (SFT). Evaluates the flexibility of the upper limbs. It measures the distance in centimeters between the tips of the fingers in the back area. Characterized as continuous numeric variable.

  Change from Baseline in Flexibility test of the upper limbs and after 12 weeks

• Body Mass Index

  the calculation will be determined by the ratio between the weight (in kilograms) and the square of height (in meters). Characterized as continuous numeric variable

  Change from Baseline in Body Mass Index and after 12 weeks

• Variation in the performance of Muscle strength Test

  Hand Grip Strength Test. Continuous numeric variable: average kilogram-force (KgF)

  Change from Baseline in Muscle strength Test after 12 weeks

Secondary Outcomes (1)

• Quality of life

  Change from Baseline in Quality of life after 12 weeks

Other Outcomes (4)

• Weight

  Change from Baseline in Weight after 12 weeks

• Height

  Change from Baseline in Height after 12 weeks

• Total Muscle Mass Index (IMMT)

  Change from Baseline in Total Muscle Mass Index (IMMT) after 12 weeks

Study Arms (2)

Control

NO INTERVENTION

The control group will be accompanied according to the service routine.

Exercise

EXPERIMENTAL

The group will be instructed to perform home exercises autonomously for range of motion and muscular fitness

Other: Home exercise

Interventions

Home exercise OTHER

Will be offered to the group, instructional material (manual exercises) and point you to an exercise routine to be performed independently for range of motion and muscular fitness, using the environmental resources of the same household. A daily frequency in performing this exercise routine is suggested. Also, be given incentives and guidelines for the practice of active commuting (walking) to be accumulated at least 10 to 20 minutes of this activity daily. All control guidelines and training for the use of the exercise manual will be offered through an introductory lecture and subsequent weekly telephone contacts (2 times a week). The participants in this group should fulfill their respective program for a total period of 12 weeks.

Also known as: Exercise

Exercise

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer diagnosis with stage I or II;
• Being in treatment for breast cancer (chemotherapy; radiotherapy and / or hormone therapy).

You may not qualify if:

• Absolute contraindication for physical exercises;
• Severe depression diagnosis using the Geriatric Depression Scale;
• Malnutrition (wasting grades I, II and III), detected by body mass index (BMI), according to the WHO criteria.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead
• Ministry of Health, Brazil: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• João Guilherme Bezerra Alves, Doctor

  Instituto de Medicina Integral Prof. Fernando Figueira

  STUDY DIRECTOR

• Breno Augusto Bormann de Souza Filho, Graduate

  Instituto de Medicina Integral Prof. Fernando Figueira

  PRINCIPAL INVESTIGATOR

• José Roberto da Silva Junior, Master

  Instituto de Medicina Integral Prof. Fernando Figueira

  STUDY DIRECTOR

• William Serrano Smethurst, Master

  Instituto de Medicina Integral Prof. Fernando Figueira

  STUDY DIRECTOR

• JuremaTelles de Oliveira Lima, Master

  Instituto de Medicina Integral Prof. Fernando Figueira

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Health

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: April 3, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-09