Chronic Obstructive Pulmonary Disease ModeratePhase 2/3NCT04386590
Manual Therapy in Addition to Pulmonary Rehabilitation in Moderate Chronic Obstructive Pulmonary Disease.
A Phase 2/3 study testing Manual Therapy Plus Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease Moderate, run by Canandaigua VA Medical Center at 1 site in United States.
Trial summary
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Moderate
- What is being tested?
- Manual Therapy Plus Pulmonary Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 2 Nov 2023
- Phase
- Phase 2/3
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: Male and Female
- Age range: 50-70 years
- Disease status: Moderate COPD (FEV1% predicted: moderate 50-80% (GOLD 2018))
- Concomitant disease status: Stable COPD (no exacerbations in preceding 6 months) Non-smoking (for preceding 6 months)
- Willingness to give written informed consent.
- Willingness to participate in and comply with the study requirements.
Who cannot join
- Inability to complete 6-minute walking test unassisted
- Contra-indicated to thoracic spinal manipulation
- Thoracic joint instability
- Acute pain on thoracic joint range of motion testing
- High level of anxiety related to receiving thoracic spinal manipulation
- Inability to understand English
- People with a cognitive impairment, an intellectual disability or a mental illness
- Completed a pulmonary rehabilitation program in the previous 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Syracuse VA Medical Center
Syracuse, New York, 13210
Emily McCormick, BA, 315-425-4400 ext. 53538, emily.mccormick@va.gov
Lori Gould, BA, 315-425-4400 ext. 53538, lori.gould@va.gov
About this study
Official title: Including Manual Therapy in Pulmonary Rehabilitation Programs for US Veterans With Moderate Chronic Obstructive Pulmonary Disease: A Feasibility Study
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.
Read the detailed description
In 2016, the US Congress directed the Department of Defense to initiate a program to improve the health and well-being of all military Veterans, challenging the research and scientific communities to find original ideas that "foster new directions in research and clinical care". One of the areas identified as a priority under this initiative was 'Respiratory Health'.
Chronic obstructive pulmonary disease (COPD) is a major cause of disability, hospital admission and premature death. Current management strategies have not been successful in altering the loss of lung function typically seen as the disease progresses. Results from recent pilot trials suggest the novel combination of chiropractic manual therapy (CMT) and pulmonary rehabilitation (PR) has the potential to alter the typical pattern of decline in lung function.
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.
Twenty Veterans between the ages of 50 and 70 years with moderate COPD, will be randomly allocated to two equal groups. Group 1: 'sham' manual therapy plus pulmonary rehabilitation program; Group 2: Chiropractic manual therapy group plus the same pulmonary rehabilitation program (CMT+PR). Participants in both groups will undergo 8 treatment sessions over a 4 week period plus an additional assessment session at week 8. All sham manual therapy and CMT will be delivered just prior to pulmonary rehabilitation.
The primary purpose of the study is to assess the feasibility of conducting a larger randomized controlled trial by assessing the ability to recruit, enroll, deliver interventions and collect outcome measures on Veterans with moderate COPD. Secondary outcomes include lung function (Forced expiratory volume in the 1st second: FEV1 and Forced vital capacity: FVC), exercise capacity (six-minute walking test: 6MWT), quality of life (St Georges Respiratory Questionnaire: SGRQ), anxiety and depression levels (Hospital Anxiety and Depression scale: HAD) and frequency of exacerbations. All outcome measurements will be taken by blinded assessors.
Collecting outcome measurements at 8 weeks (4 weeks after intervention has ceased) will assess the feasibility of getting Veterans to return for follow-up assessments.
- Being tested
- Manual Therapy Plus Pulmonary Rehabilitation, Sham Intervention
- Keywords
- manual therapy, respiratory therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy Plus Pulmonary RehabilitationOther
Manual therapy combined with Pulmonary Rehabilitation
Sham InterventionOther
Detuned US plus Pulmonary Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| 'Sham' manual therapy plus Pulmonary Rehabilitation (PR) | Sham comparator | Treadmill walking, upper body exercise machine, light weight training and bicycle. These exercises are supervised. In addition to the standard exercise therapy, all participants will undergo a 20-minute session consisting of discussion with the patient and 11 minutes of detuned ultrasound, which has been used in previous studies to account for time and attention for the patient. The detuned ultrasound procedure is to apply the ultrasound gel and turn the machine on, but set the intensity at zero (0) W/cm2 Receives: Other: Sham Intervention |
| Manual therapy plus Pulmonary Rehabilitation (CMT+ | Experimental | Manual therapy is made up of gentle Effleurage and cross-fibre friction massage applied to the muscles of the posterior chest wall. Manual Therapy consists of two separate manipulations (Grade V mobilization). Each manipulation involves the delivery of a high-velocity low amplitude (HVLA) posterior to anterior force directed at the inter-vertebral, costo-vertebral and costo-transverse joints. The first manipulation is delivered at the level of the upper/middle thoracic spine while the second is at the level of the middle/lower thoracic spine. In addition to the MT, the participant will also undergo Pulmonary Rehab as previously described. Receives: Other: Manual Therapy Plus Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry
Lung function (Forced expiratory volume in the 1st second: FEV1 and forced vital capacity: FVC) will be assessed using spirometry.
Measured: Change from Baseline to Post Intervention (4 weeks post baseline)
Secondary outcomes (3)
6 Minute Walking Test (6MWT)
Exercise capacity will be assessed using a six-minute walking test (6MWT) where capacity is determined by the total distance walked in a period of six minutes. Greater walking distance indicates greater functional capacity.
Measured: Change from baseline to post intervention (4 weeks post baseline)
St Georges Respiratory Questionnaire: SGRQ
Quality of life questionnaire for those with COPD. Scores are calculated for three domains: Symptoms, activity and Impacts (psychosocial) and total score. Higher scores indicate more limitations.
Measured: Change from baseline to post intervention (4 weeks post baseline)
Hospital Anxiety and Depression scale: HAD
Questionnaire assessing anxiety and depression in outpatient hospital setting. Higher scores indicate greater levels of anxiety and depression.
Measured: Change from baseline to post intervention (4 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start15 Jun 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion2 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease ModerateStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty Veterans between the ages of 50 and 70 years with moderate COPD, will be randomly allocated to two equal groups. Group 1: 'sham' manual therapy plus pulmonary rehabilitation program; Group 2: Chiropractic manual therapy group plus the same pulmonary rehabilitation program (CMT+PR). Participants in both groups will undergo 8 treatment sessions over a 4 week period plus an additional assessment session at week 8. All sham manual therapy and CMT will be delivered just prior to pulmonary rehabilitation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canandaigua VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Paul Dougherty, DC, Canandaigua VA Medical Center
- Investigators
- Paul E Dougherty, DC, Principal investigator, VA Finger Lakes Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386590
- Sponsor's protocol ID
- 1474325
- Status last verified
- Mar 2022
- First submitted
- 4 May 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the phase of this study, the data will be utilized to inform the design of a larger clinical trial. Data from the larger study will be available to share de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Including Manual Therapy in Pulmonary Rehabilitation Programs for US Veterans With Moderate Chronic Obstructive Pulmonary Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04386590
- Acronym / sponsor ID
- 1474325
- Keywords
- manual therapy, respiratory therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Canandaigua VA Medical CenterUS federal agency
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 2 Nov 2023 (estimated)
- First posted
- 13 May 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.
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.
Detailed description
In 2016, the US Congress directed the Department of Defense to initiate a program to improve the health and well-being of all military Veterans, challenging the research and scientific communities to find original ideas that "foster new directions in research and clinical care". One of the areas identified as a priority under this initiative was 'Respiratory Health'.
Chronic obstructive pulmonary disease (COPD) is a major cause of disability, hospital admission and premature death. Current management strategies have not been successful in altering the loss of lung function typically seen as the disease progresses. Results from recent pilot trials suggest the novel combination of chiropractic manual therapy (CMT) and pulmonary rehabilitation (PR) has the potential to alter the typical pattern of decline in lung function.
The aim of this study is to investigate the feasibility of administering this combination of interventions (CMT plus PR) to Veterans with moderate COPD within the context of a hospital-based outpatient pulmonary rehabilitation program.
Twenty Veterans between the ages of 50 and 70 years with moderate COPD, will be randomly allocated to two equal groups. Group 1: 'sham' manual therapy plus pulmonary rehabilitation program; Group 2: Chiropractic manual therapy group plus the same pulmonary rehabilitation program (CMT+PR). Participants in both groups will undergo 8 treatment sessions over a 4 week period plus an additional assessment session at week 8. All sham manual therapy and CMT will be delivered just prior to pulmonary rehabilitation.
The primary purpose of the study is to assess the feasibility of conducting a larger randomized controlled trial by assessing the ability to recruit, enroll, deliver interventions and collect outcome measures on Veterans with moderate COPD. Secondary outcomes include lung function (Forced expiratory volume in the 1st second: FEV1 and Forced vital capacity: FVC), exercise capacity (six-minute walking test: 6MWT), quality of life (St Georges Respiratory Questionnaire: SGRQ), anxiety and depression levels (Hospital Anxiety and Depression scale: HAD) and frequency of exacerbations. All outcome measurements will be taken by blinded assessors.
Collecting outcome measurements at 8 weeks (4 weeks after intervention has ceased) will assess the feasibility of getting Veterans to return for follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty Veterans between the ages of 50 and 70 years with moderate COPD, will be randomly allocated to two equal groups. Group 1: 'sham' manual therapy plus pulmonary rehabilitation program; Group 2: Chiropractic manual therapy group plus the same pulmonary rehabilitation program (CMT+PR). Participants in both groups will undergo 8 treatment sessions over a 4 week period plus an additional assessment session at week 8. All sham manual therapy and CMT will be delivered just prior to pulmonary rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| 'Sham' manual therapy plus Pulmonary Rehabilitation (PR) | Sham comparator | Other: Sham InterventionTreadmill walking, upper body exercise machine, light weight training and bicycle. These exercises are supervised. In addition to the standard exercise therapy, all participants will undergo a 20-minute session consisting of discussion with the patient and 11 minutes of detuned ultrasound, which has been used in previous studies to account for time and attention for the patient. The detuned ultrasound procedure is to apply the ultrasound gel and turn the machine on, but set the intensity at zero (0) W/cm2 |
| Manual therapy plus Pulmonary Rehabilitation (CMT+ | Experimental | Other: Manual Therapy Plus Pulmonary RehabilitationManual therapy is made up of gentle Effleurage and cross-fibre friction massage applied to the muscles of the posterior chest wall. Manual Therapy consists of two separate manipulations (Grade V mobilization). Each manipulation involves the delivery of a high-velocity low amplitude (HVLA) posterior to anterior force directed at the inter-vertebral, costo-vertebral and costo-transverse joints. The first manipulation is delivered at the level of the upper/middle thoracic spine while the second is at the level of the middle/lower thoracic spine. In addition to the MT, the participant will also undergo Pulmonary Rehab as previously described. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sex: Male and Female
- Age range: 50-70 years
- Disease status: Moderate COPD (FEV1% predicted: moderate 50-80% (GOLD 2018))
- Concomitant disease status: Stable COPD (no exacerbations in preceding 6 months) Non-smoking (for preceding 6 months)
- Willingness to give written informed consent.
Key exclusion criteria (8 listed)
- Inability to complete 6-minute walking test unassisted
- Contra-indicated to thoracic spinal manipulation
- Inability to understand English
- People with a cognitive impairment, an intellectual disability or a mental illness
- Completed a pulmonary rehabilitation program in the previous 12 months
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 |
|---|---|---|
| Manual Therapy Plus Pulmonary RehabilitationManual therapy combined with Pulmonary Rehabilitation | Other | Manual therapy plus Pulmonary Rehabilitation (CMT+ |
| Sham InterventionDetuned US plus Pulmonary Rehabilitation | Other | 'Sham' manual therapy plus Pulmonary Rehabilitation (PR) |
Primary outcome
Spirometry
Time frame: Change from Baseline to Post Intervention (4 weeks post baseline)
Lung function (Forced expiratory volume in the 1st second: FEV1 and forced vital capacity: FVC) will be assessed using spirometry.
3 secondary outcomes
6 Minute Walking Test (6MWT)
Time frame: Change from baseline to post intervention (4 weeks post baseline)
St Georges Respiratory Questionnaire: SGRQ
Time frame: Change from baseline to post intervention (4 weeks post baseline)
Hospital Anxiety and Depression scale: HAD
Time frame: Change from baseline to post intervention (4 weeks post baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No. Due to the phase of this study, the data will be utilized to inform the design of a larger clinical trial. Data from the larger study will be available to share de-identified data.
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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.
Paul E Dougherty, DC principal investigator
VA Finger Lakes Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Manual Therapy Plus Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease Moderate, run by Canandaigua VA Medical Center at 1 site in United States.
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 8 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul E Dougherty, DC (315-945-7381, paul.dougherty@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry (time frame: Change from Baseline to Post Intervention (4 weeks post baseline)). 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 31 Mar 2022.