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临床试验/NCT04345211
NCT04345211已完成不适用

The Effect of Manual Therapy, Thera-band Exercise and Walking on Age-related Lung Function and Functional Capacity

University of Valencia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Pulmonary function

研究概览

简要总结

Worldwide, the number of older adults is expected to more than double by 2050 and more than triple by 2100, with most of the increase in developing countries. This situation has become a challenge to health professions such as physical therapy, since aging involves a gradual reduction in the capacity to adapt and an increase in vulnerability to health issues such as chronic non-communicable diseases and musculoskeletal disorders. The respiratory system, as the rest of the body, is exposed to both physiological aging and disease. According to the World Health Organization , respiratory diseases such as trachea, bronchi, or lung cancer, lower respiratory tract infections, or chronic obstructive pulmonary disease are found in the third, fifth, and sixth cause of death, respectively, among the top ten.

Therefore, bronchopulmonary and thoracic pathology constitutes an important problem for Public Health, both due to the high number of affected subjects and to their potential severity For this reason, the recommendations of the European, North American and national societies, highlight, among other aspects, the importance of the prevention of these diseases. They also insist on the need to maintain the integrity of the thoraco-abdominal anatomical elements and preventive treatment in those at risk, before symptoms appear. These recommendations together with the change of perspective that is being taken into account when treating aging have led to the fact that in the last decade more research has been started on the respiratory system in older people without respiratory problems.

The aim of this trial is to investigate whether manual therapy, elastic band exercise or walking can mitigate the effects of age-related changes in lung function in adults over 60 years old. Also whether there is a difference in effect between the different forms of therapy.

详细描述

Study design A 4-week program will be implemented with sessions 2 days a week, 45-60 minutes per session. It would be convenient for each group to have 30 participants each. Group1: walking group. 40 minutes walking with supervision of the physiotherapist. 2 times per week.; Group 2: walking (40 minutes) plus self-administered thorax manual therapy (20 minutes). It will be applied in group and supervised by a physiotherapist. 2 times per week.; Group 3: walking (40 minutes) plus thorax exercises with elastic-band (20 minutes). It will be applied in group and supervised by a physiotherapist. 2 times per week.;Group 4: control group will do usual life and assessments as the rest of the groups.

Oucome measures Pulmonary function: pulmonary function evaluation via forced spirometry dynamic lung volumes (forced vital capacity, FVC; forced expired volume at 1 second, FEV1). Chest wall expansion: A measuring tape is used to measure chest expansion in centimetres (cm) at two levels of the rib cage: upper chest expansion and lower chest. Exercise tolerance: 6 Six Minute Walk Test. Smoking Index. The smoking index is a unit for measuring cigarettes consumption over a long period. Musculoskeletal Pain: visual analog scale. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Perception of change after treatment: Patient Global Impression of Improvement. Quality of life. Trigger points pain: by algometer. Change in thorax position: Distance between acromion-bed. Functional capacity: Sit-to-stand. Frailty: FRAIL Questionnaire. Motivation and self-efficacy: Participation motives are measured with the Exercise Motivation Index.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults between 60-85 years old.
  • •Male and female
  • •No history of respiratory or cardiac disease
  • •Currently non-smoking (> 6 months)
  • •Willingness to provide written consent
  • •Willingness to participate in and comply with study requirements

排除标准

  • •Adults over 85 years old.
  • •History of respiratory pathology.
  • •History of cardiac pathology.
  • •Inability to walk unaided and unassisted
  • •Acute pain on thoracic joint range of motion testing
  • •Contra-indicated for thoracic mobilisation and/or manipulation (physical screening examination)
  • •Inability to provide informed consent, e.g. people with a cognitive impairment, intellectual disability or mental illness

研究组 & 干预措施

Group1 (G1): walking group

Active Comparator

All walks will be done immediately after the MT and TB intervention, as this has been shown to improve the synergistic effect of combining the two interventions. The walking sessions will be organized twice a week. The walking sessions will begin with a 10-minute warm-up. After warming up, you will take a continuous walk for 10-20 min, at a target intensity of 13 ("somewhat difficult") on the Borg scale. Using the Borg scale, which ranges from 6 to 20, participants will be asked to walk at an intensity of 13 (perception of "somewhat difficult" activity). Each session will be completed with a 10 minute cool down period. The objectives of Walinking will be individualized according to the level of physical condition of each participant. The walking group will include a weekly walking goal of 75 minutes.

干预措施: Group1, walking group (Other)

Group 2 (G2): walking plus manual therapy

Active Comparator

Walking as previously described plus a self-administered manual chest therapy:

  • Neurolymphatic points pressure: Participants will be placed in a neutral position and their arms next to their bodies. They are asked to take a conscious breath. The physical therapist will apply firm, direct rotary pressure through the thumb or fingertip for 1 minute from the T1 transverse processes to the T12 transverse processes. Suboccipital decompression / mobilization, slippage of the cervical vertebral joints (anterior / posterior), myofascial release of sternocleidomastoid and trapezius, slippage of the sternoclavicular joint (anterior / posterior direction), myofascial release of intercostal muscles and paravertebral muscles (anterior rib mobilization, posterior, lateral), mobilization of the scapulothoracic joint, diaphragmatic release.

干预措施: Group 2, Walking plus manual therapy (Other)

Group 3 (G3): walking plus thorax exercises with Theraband.

Active Comparator

Walking as previously described plus a self-administered exercises with elastic-band. The exercises will include chest and arms exercises in sitting position.

干预措施: Group 3; Walking plus exercises with Theraband (Other)

Group 4 (G4): control group

No Intervention

Control group will do usual life and assessments as the rest of the groups.

结局指标

主要结局

Pulmonary function

时间窗: 4-8 week

pulmonary function evaluation via forced spirometry dynamic lung volumes (forced vital capacity, FVC; forced expired volume at 1 second, FEV1).

次要结局

  • Chest expansion(4-8 week)
  • Perception of change after treatment(4-8 week)
  • Trigger points pain(4-8 week)
  • Change in thorax position(4-8 week)
  • Motivation and self-efficacy(4-8 week)
  • Frailty(4-8 week)
  • Screening sarcopenia(4-8 week)
  • Musculoskeletal Pain(4-8 week)
  • Exercise tolerance(4-8 week)
  • Functional capacity(4-8 week)
  • Smoking(4-8 week)
  • Perception of Quality of life(4-8 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

研究点 (1)

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