AgingMTBEWNCT04345211
Manual Therapy, Thera-band Exercise and Walking
A study testing Group1, walking group, Group 2, Walking plus manual therapy and Group 3; Walking plus exercises with Theraband in people with Aging, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Group1, walking group, Group 2, Walking plus manual therapy and Group 3; Walking plus exercises with Theraband
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2021to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Manual Therapy, Thera-band Exercise and Walking on Age-related Lung Function and Functional Capacity
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Group1, walking group, Group 2, Walking plus manual therapy, Group 3; Walking plus exercises with Theraband
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1, walking groupOther
The walking group includes a weekly walking goal of 75 minutes.
Group 2, Walking plus manual therapyOther
Walking plus self-administered thorax manual therapy
Group 3; Walking plus exercises with TherabandOther
Walking plus thorax exercises with Theraband
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
pulmonary function evaluation via forced spirometry dynamic lung volumes (forced vital capacity, FVC; forced expired volume at 1 second, FEV1).
Measured: 4-8 week
Secondary outcomes (12)
Chest 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.
Measured: 4-8 week
Exercise tolerance
6 Six Minute Walk Test (6MWT). The object of this test is to walk as far as possible for 6 minutes. The patient will walk back and forth around the cones in a hallway and is permitted to slow down, to stop, and to rest as necessary (but resume walking as soon as able).
Measured: 4-8 week
Smoking
The smoking index is a unit for measuring cigarettes consumption over a long period and was calculated using the following formula:
Smoking index = Cigarettes Smoked per Day (CPD)× years of tobacco use.
Smoking index categories were non-smoker, <400, 400-799, and ≥800. The CPD was estimated for current and former smokers. We defined heavy smoking as ≥20 CPD and mild smoking as <20 CPD.
The smoking index is a unit for measuring cigarettes consumption over a long period and was calculated using the following formula:
Smoking index = Cigarettes Smoked per Day (CPD)× years of tobacco use.
Smoking index categories were non-smoker, <400, 400-799, and ≥800. The CPD was estimated for current and former smokers. We defined heavy smoking as ≥20 CPD and mild smoking as <20 CPD.
Measured: 4-8 week
Musculoskeletal Pain
visual analog scale (VAS). The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.
Measured: 4-8 week
Perception of change after treatment
By Patient Global Impression of Improvement (PGIC).
Measured: 4-8 week
Perception of Quality of life
By SF-8 scale. The SF-8 consists of 8 items comprising 8 dimensions (Bodily Pain, Perceptions, Mental Health, Physical Function, Role-physical, Role-emotional, Social Function, and Vitality).
To assess each dimension, items are aggregated into a score ranging from 0 to 100; being higher scores indicators of good health.
Measured: 4-8 week
Trigger points pain
By algometer. Pressure was applied perpendicular to the skin, at a speed of 30kPa/s. Three measurements with 1 minute between measurements were averaged.
Measured: 4-8 week
Change in thorax position
Distance between acromion-bed.To assess the position of the upper trunk, the length of the pectoralis minor in the supine position is evaluated by measuring the distance between the posterior edge of the acromion and the stretcher while the patients remain in that position.
Measured: 4-8 week
Functional capacity
By Sit-to-stand test. Participants sit in a 43 cm tall armless chair (Fig. 1) as quickly as possible 5 times. Participants cross their arms over their chest and are instructed to fully stand up and make firm contact when sitting. Time begins with the "go" command and ends when participants sit down after the fifth stand-up.
Measured: 4-8 week
Frailty
By FRAIL Questionnaire. The FRAIL scale are short 5-question assessment of fatigue, resistance, aerobic capacity, illnesses, and loss of weight, classified the patients into 3 categories: robust (score = 0), prefrail (score = 1-2), and frail (score = 3-5).
Measured: 4-8 week
Motivation and self-efficacy
Participation motives are measured with the Exercise Motivation Index. The questionnaire consists of 15 statements followed by a five-point rating scale for each statement, ranging from 0 (not important) to 4 (extremely important). Although the authors found that the index was valid and reliable, they advise that further validation be made. Three subscores (0-4) were calculated by summing the scores for physical, psychological, and social motivation and dividing them by the number of statements for each area (Stenström, 1997; Klompstra, 2015) Cronbach's alpha was 0.889.
Measured: 4-8 week
Screening sarcopenia
Screening sarcopenia: SARC-F. There are 5 components of SARC-F questionnaire: strength, assistance with walking, rise from a chair, climb stairs, and fall. The SARC-F scores range from 0 to 10, with 0 to 2 points for each component. A score ≥4 is predictive of sarcopenia and poor outcomes.
Measured: 4-8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start25 Oct 2021
- Primary completion30 Jan 2022
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V Espí-López, Dr, Principal investigator, Faculty of Physiotherapy. University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345211
- Sponsor's protocol ID
- ID0029
- Acronym
- MTBEW
- Status last verified
- May 2023
- First submitted
- 5 Apr 2020
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Therapy, Thera-band Exercise and Walking on Age-related Lung Function and Functional Capacity
- ClinicalTrials.gov ID
- NCT04345211
- Acronym / sponsor ID
- MTBEW / ID0029
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 (G1): walking group | Active comparator | Other: Group1, walking groupAll 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. |
| Group 2 (G2): walking plus manual therapy | Active comparator | Other: Group 2, Walking plus manual therapyWalking 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. |
| Group 3 (G3): walking plus thorax exercises with Theraband. | Active comparator | Other: Group 3; Walking plus exercises with TherabandWalking as previously described plus a self-administered exercises with elastic-band. The exercises will include chest and arms exercises in sitting position. |
| Group 4 (G4): control group | No intervention | –Control group will do usual life and assessments as the rest of the groups. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group1, walking groupThe walking group includes a weekly walking goal of 75 minutes. | Other | Group1 (G1): walking group |
| Group 2, Walking plus manual therapyWalking plus self-administered thorax manual therapy | Other | Group 2 (G2): walking plus manual therapy |
| Group 3; Walking plus exercises with TherabandWalking plus thorax exercises with Theraband | Other | Group 3 (G3): walking plus thorax exercises with Theraband. |
Primary outcome
Pulmonary function
Time frame: 4-8 week
pulmonary function evaluation via forced spirometry dynamic lung volumes (forced vital capacity, FVC; forced expired volume at 1 second, FEV1).
12 secondary outcomes
Chest expansion
Time frame: 4-8 week
Exercise tolerance
Time frame: 4-8 week
Smoking
Time frame: 4-8 week
Musculoskeletal Pain
Time frame: 4-8 week
Perception of change after treatment
Time frame: 4-8 week
Perception of Quality of life
Time frame: 4-8 week
Trigger points pain
Time frame: 4-8 week
Change in thorax position
Time frame: 4-8 week
Functional capacity
Time frame: 4-8 week
Frailty
Time frame: 4-8 week
Motivation and self-efficacy
Time frame: 4-8 week
Screening sarcopenia
Time frame: 4-8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma V Espí-López, Dr principal investigator
Faculty of Physiotherapy. University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group1, walking group, Group 2, Walking plus manual therapy and Group 3; Walking plus exercises with Theraband in people with Aging, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: 4-8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.