Clinical trial NCT04345211: Manual Therapy, Thera-band Exercise and Walking
Official title: The Effect of Manual Therapy, Thera-band Exercise and Walking on Age-related Lung Function and Functional Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pulmonary function
timeFrame: 4-8 week
Secondary outcomes:
measure: Chest expansion
timeFrame: 4-8 week
measure: Exercise tolerance
timeFrame: 4-8 week
measure: Smoking
timeFrame: 4-8 week
measure: Musculoskeletal Pain
timeFrame: 4-8 week
measure: Perception of change after treatment
timeFrame: 4-8 week
measure: Perception of Quality of life
timeFrame: 4-8 week
measure: Trigger points pain
timeFrame: 4-8 week
measure: Change in thorax position
timeFrame: 4-8 week
measure: Functional capacity
timeFrame: 4-8 week
measure: Frailty
timeFrame: 4-8 week
measure: Motivation and self-efficacy
timeFrame: 4-8 week
measure: Screening sarcopenia
timeFrame: 4-8 week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Espí
Study officials:
affiliation: Faculty of Physiotherapy. University of Valencia
name: Gemma V Espí-López, Dr
role: PRINCIPAL_INVESTIGATOR
References: