Physical Exercise in the Quality of Life and Physical Fitness of Elderly Women With Breast Cancer

NCT03226782 | Completed

• 1 other identifier: U1111-1191-6340
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

Among the possibilities of intervention to minimize the effects of cancer treatment, the exercises are efficient in improving the physical fitness and quality of life of the elderly in treatment. The goal is to compare the effects of two home physical exercise protocols on quality of life and physical fitness of elderly people with breast cancer who are in hormone use. A study was carried out at the Institute of Integral Medicine Professor Fernando Figueira (IMIP) within the Professional Master Program in Palliative Care Associated with the Residency Program in Health, which evaluated the effectiveness of a protocol of 29 exercises with walking sessions, performed at home , In the quality of life and physical fitness of the elderly in the treatment of breast cancer. The results of the mentioned research showed that the elderly showed improvement both in quality of life and physical fitness. In view of the results and the clinical and functional kinetic observation of these patients, the hypothesis was that a shorter intervention protocol, with fewer exercises with fewer repetitions and a lower degree of difficulty can bring results similar to those found, requiring a shorter time In the accomplishment of the exercises, which can favor the adherence to the protocol by the patients, still achieving positive results in their quality of life and physical fitness. The elderly will undergo evaluations to characterize the sample through questionnaires, the physical fitness assessment will be performed through the Senior Fitness Test (SFT) and anthropometric evaluation before (beginning of the research), in the 6th week and after the 12th week of the research. It will be offered the elderly, instructional material developed for this research - printed manual. It will consist of a routine of 12 exercises to be performed autonomously for range of motion and muscular fitness, using the environmental resources of the home. All control and training guidelines for using the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises. The control group used a protocol with 29 home exercises in a longer manual. The results will be obtained from the statistical package SPSS 10.0 for Windows and a p \<0.05 will be accepted.

Conditions

Breast Cancer; Physical Activity; Physical Fitness; Quality of Life

Outcome Measures

Primary Outcomes (8)

• 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 after 6 and 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 6 and 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) after 6 and 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 after 6 and 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 after 6 and 12 weeks

• Variation in the performance of Sit and Reach Modified test

  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) after 6 and 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 after 6 and 12 weeks

• Variation in the performance of Muscle strength Test

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

  Change from Baseline in Muscle strength Test after 6 and 12 weeks

Secondary Outcomes (1)

• Quality of life

  Change from Baseline in Quality of life after 12 weeks

Study Arms (2)

Short intervention protocol

ACTIVE COMPARATOR

Will be offered an instructional material that will consist of a routine of 12 exercises to be performed autonomously for range of motion and muscular fitness, using the environmental resources of the home. It will be suggested a daily frequency in the execution of this exercise routine. Also, stimuli and guidelines will be given for the practice of active movement (walking) so that they accumulate at least 10 to 20 minutes of this activity daily. All control and training guidelines for using the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises.

Other: Short intervention protocol

Long Intervention protocol

ACTIVE COMPARATOR

Consisting of 29 exercises to be performed at home. The guideline is to perform each exercise 6 to 8 times in a gentle manner keeping your attention on movement. This Manual guides its implementation in a progressive way and at the end it totals about 30 to 45 min of physical exercises per day. All control and training guidelines for use of the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises. Therefore, it guides the implementation of daily walks with cumulative effect.

Other: Long intervention protocol

Interventions

Short intervention protocol OTHER

Will be offered an instructional material that will consist of a routine of 12 exercises to be performed autonomously for range of motion and muscular fitness, using the environmental resources of the home. It will be suggested a daily frequency in the execution of this exercise routine. Also, stimuli and guidelines will be given for the practice of active movement (walking) so that they accumulate at least 10 to 20 minutes of this activity daily. All control and training guidelines for using the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises.

Short intervention protocol

Long intervention protocol OTHER

This Manual guides its implementation in a progressive way and at the end it totals about 30 to 45 min of physical exercises per day. All control and training guidelines for use of the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises. Therefore, it guides the implementation of daily walks with cumulative effect.

Long Intervention protocol

Eligibility Criteria

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

You may qualify if:

• Have a diagnosis of breast cancer, with staging I or II;
• Being in treatment for breast cancer (hormone therapy);

You may not qualify if:

• Severe depression assessed by the Geriatric Depression Scale
• Malnutrition (degrees I, II and III), detected by the Body Mass Index (BMI), according to WHO criteria.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• JOSE ROBERTO DA SILVA JUNIOR, DOCTORATE

  Instituto de Medicina Integral Professor Fernando Figueira

  PRINCIPAL INVESTIGATOR

• ANA CLARA CARVALHO GONÇALVES GUERRA, MASTER

  Instituto de Medicina Integral Professor Fernando Figueira

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: José Roberto da Silva Junior

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: August 15, 2016
• Primary Completion: February 11, 2017
• Study Completion: February 11, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share