Comparison of the Effect of Two Household Physical Exercise Protocols in the Quality of Life and Physical Fitness of Elderly Women With Breast Cancer in Hormoniotherapy Treatment: Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- Variation in the performance of Flexion forearm Test
研究概览
简要总结
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.
详细描述
For the calculation of the sample size, performed in the program Stata 12 version 12, the results presented in the dissertation of Souza Filho and collaborators were considered. The results of the "Raise" test at the end of the study presented a mean of 14.55 ± 3.12 in the intervention group and a mean of 11.16 ± 2.66 in the control group. A 99% power and a type I error of 5% would require 27 patients In each group. Predicting eventual losses, this number was estimated for 33 patients in each group.
The elderly will be considered in two groups, one group will participate in a program of 29 exercises and a second group will participate in a short program with 12 exercises, will be developed according to the following parameters:
Group 1: A manual will be offered, 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. The first 19 exercises were of range of motion:
- Stretching of buttocks in dorsal decubitus position
- Trunk side chain elongation in dorsal decubitus
- Stretching of hip adductors adopting the "butterfly posture"
- Global mobilization of the spine by adopting the posture of cats
- Ankle Mobilization
- Mobilization of the toes
- Circular ankle mobilization
- Self-passive ankle mobilization with sitting individual and flexed hip and knee.
- Mobilization of the thoracic spine in the sitting posture.
- Trunk side chain elongation in sitting posture
- Dislocation of scapular girdle
- Pelvic girdle dissociation
- Cervical lateral inclination
- Flexion and cervical extension
- Cervical rotational movement (global mobilization)
- Abduction and flexion of the shoulder
- Internal and external rotation of the shoulder
- Arms at the front of the body at the shoulder line, the movement consists of performing scapular abduction and lengthening of the flexors at the same time
- Mobilization of hand and fingers.
The 10 subsequent exercises are muscular fitness: 20. Sit-up to strengthen mainly of the musculature of the quadriceps and glutes 21. Sits-ups modified 22. Strengthening of pectoral and biceps 23. Strengthening of pectoral and modified biceps 24. Gastrocnemius and soleus strengthening. 25. Gastrocnemius strengthening and modified soleus 26. Exercise of balance and coordination 27. Strengthening of the brachial and iliopsoas triceps 28. Brachial triceps strengthening 29. Brachial triceps strengthening 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be between 60 and 74 years old;
- •Have a diagnosis of breast cancer, with staging I or II;
- •Being in treatment for breast cancer (hormone therapy);
排除标准
- •Absolute contraindication for performing physical exercises
- •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.
研究组 & 干预措施
Short intervention protocol
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.
干预措施: Short intervention protocol (Other)
Long Intervention protocol
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.
干预措施: Long intervention protocol (Other)
结局指标
主要结局
Variation in the performance of Flexion forearm Test
时间窗: Change from Baseline in Flexion forearm Test and after 6 and 12 weeks
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.
Variation in the performance of Six Minute Walk Test (6MWT)
时间窗: Change from Baseline in Six Minute Walk Test (6MWT) after 6 and 12 weeks]
Test which comprises the Battery Senior Fitness Test (SFT). Evaluates aerobic endurance. Total meters walked for 6 minutes walk. Characterized as continuous numeric variable.
Variation in the performance of March Stationary two minutes Test
时间窗: Change from Baseline in March Stationary two minutes Test after 6 and 12 weeks
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.
Variation in the performance of Skip and Vir 2.44 meters test
时间窗: Change from Baseline in Skip and Vir 2.44 meters test after 6 and 12 weeks
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.
Variation in the performance of Sit and Reach Modified test
时间窗: Change from Baseline in Sit and Reach Modified test (In the Chair) after 6 and 12 weeks
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.
Variation in the performance of Flexibility test of the upper limbs
时间窗: Change from Baseline in Flexibility test of the upper limbs after 6 and 12 weeks
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
Variation in the performance of Muscle strength Test
时间窗: Change from Baseline in Muscle strength Test after 6 and 12 weeks
Hand Grip Strength Test. Continuous numeric variable: average kilogram-force
Variation in the performance of Lift and Sitting Test
时间窗: Change from Baseline in Lift and Sitting Test after 6 and 12 weeks
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
次要结局
- Quality of life(Change from Baseline in Quality of life after 12 weeks)
研究者
José Roberto da Silva Junior
José Roberto da Silva Junior
Professor Fernando Figueira Integral Medicine Institute