Trial Outcomes & Findings for Effects of Vibration Training on Exercise Capacity in COPD-patients (NCT NCT01380639)

NCT ID: NCT01380639

Last Updated: 2019-04-30

Results Overview

Change in 6-minute-walking-distance from baseline to day 19

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

day 1, day 19

Results posted on

2019-04-30

Participant Flow

Enrollment of patients is meant for the number of study completers without drop out patients (n=10).

Participant milestones

Participant milestones
Measure
Rehabilitation With Vibration Training
whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
Rehabilitation Without Vibration Training
Overall Study
STARTED
42
40
Overall Study
COMPLETED
36
36
Overall Study
NOT COMPLETED
6
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Vibration Training on Exercise Capacity in COPD-patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rehabilitation With Vibration Training
n=42 Participants
whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
Rehabilitation Without Vibration Training
n=40 Participants
Total
n=82 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
22 Participants
n=99 Participants
19 Participants
n=107 Participants
41 Participants
n=206 Participants
Age, Categorical
>=65 years
20 Participants
n=99 Participants
21 Participants
n=107 Participants
41 Participants
n=206 Participants
Age, Continuous
64 years
STANDARD_DEVIATION 11 • n=99 Participants
65 years
STANDARD_DEVIATION 7 • n=107 Participants
64 years
STANDARD_DEVIATION 9 • n=206 Participants
Sex: Female, Male
Female
23 Participants
n=99 Participants
19 Participants
n=107 Participants
42 Participants
n=206 Participants
Sex: Female, Male
Male
19 Participants
n=99 Participants
21 Participants
n=107 Participants
40 Participants
n=206 Participants
Region of Enrollment
Germany
42 participants
n=99 Participants
40 participants
n=107 Participants
82 participants
n=206 Participants

PRIMARY outcome

Timeframe: day 1, day 19

Change in 6-minute-walking-distance from baseline to day 19

Outcome measures

Outcome measures
Measure
Rehabilitation With Vibration Training
n=36 Participants
whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
Rehabilitation Without Vibration Training
n=36 Participants
6-Minute-Walking-Distance
64 m
Standard Deviation 59
37 m
Standard Deviation 52

SECONDARY outcome

Timeframe: day 1 and 19

Change in body composition from baseline to day 19

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1, day 19

change in isometric max. handgrip force from baseline to day 19

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1, day 19

Change in Bode-Score from baseline to day 19

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 1, day 19

change in BNP from baseline to day 19

Outcome measures

Outcome data not reported

Adverse Events

Rehabilitation With Vibration Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Rehabilitation Without Vibration Training

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

Dr. Klaus Kenn

Schön Klinik Berchtesgadener Land

Phone: +49 8652 931541

Results disclosure agreements

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