Manual Therapy, Thera-band Exercise and Walking

NCT04345211 | Completed

• 1 other identifier: ID0029
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Pulmonary function

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

  4-8 week

Secondary Outcomes (12)

• Chest expansion

  4-8 week

• Exercise tolerance

  4-8 week

• Smoking

  4-8 week

• Musculoskeletal Pain

  4-8 week

• Perception of change after treatment

  4-8 week

Study Arms (4)

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.

Other: Group1, walking group

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.

Other: Group 2, Walking plus manual therapy

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.

Other: Group 3; Walking plus exercises with Theraband

Group 4 (G4): control group

NO INTERVENTION

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

Interventions

Group1, walking group OTHER

The walking group includes a weekly walking goal of 75 minutes.

Group1 (G1): walking group

Group 2, Walking plus manual therapy OTHER

Walking plus self-administered thorax manual therapy

Group 2 (G2): walking plus manual therapy

Group 3; Walking plus exercises with Theraband OTHER

Walking plus thorax exercises with Theraband

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

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma Espí

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Walking; Musculoskeletal Manipulations; Exercise

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gemma V Espí-López, Dr

  Faculty of Physiotherapy. University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 14, 2020
• Study Start: October 25, 2021
• Primary Completion: January 30, 2022
• Study Completion: April 28, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

ES (1)