Trial Outcomes & Findings for Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial (NCT NCT00637299)

NCT ID: NCT00637299

Last Updated: 2011-10-24

Results Overview

6 minutes walking test (6MWT)

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2011-10-24

Participant Flow

Participant milestones

Measure	Active Osteopathic Treatment OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.	Sham Osteopathic Treatment (Manipulation) Sham Osteopathic Treatment was performed applying only soft manipulation
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial

Baseline characteristics by cohort

Measure	Active Osteopathic Treatment n=10 Participants OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.	Sham Osteopathic Treatment (Manipulation) n=10 Participants Sham Osteopathic Treatment was performed applying only soft manipulation	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Age Continuous	64.2 years STANDARD_DEVIATION 5.5 • n=5 Participants	63.5 years STANDARD_DEVIATION 4.7 • n=7 Participants	63.8 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

6 minutes walking test (6MWT)

Outcome measures

Measure	Active Osteopathic Treatment n=10 Participants OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.	Sham Osteopathic Treatment (Manipulation) n=10 Participants Sham Osteopathic Treatment was performed applying only soft manipulation
Walking Ability	369.5 meters Standard Deviation 80	304.7 meters Standard Deviation 96.6

SECONDARY outcome

Timeframe: 4 weeks

residual volume (RV)

Outcome measures

Measure	Active Osteopathic Treatment n=10 Participants OMT was defined as the therapeutic application of manually guided forces by an osteopathic practitioner.	Sham Osteopathic Treatment (Manipulation) n=10 Participants Sham Osteopathic Treatment was performed applying only soft manipulation
Lung Function Test	3.09 liters Standard Deviation 1.7	4.23 liters Standard Deviation 1.4

Adverse Events

Active Osteopathic Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Osteopathic Treatment (Manipulation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ercole Zanotti

Fondazione Salvatore Maugeri

Phone: 39 385 247

Email: ercole.zanotti@fsm.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place