Trial Outcomes & Findings for Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure (NCT NCT01560871)

NCT ID: NCT01560871

Last Updated: 2020-04-03

Results Overview

This questionnaire includes 21 questions which ask how much the heart condition affected the patient's life during the past month. Each question has 5 optional answers with the scores ranging from 0 to 5. A higher score indicates a worse outcome. The minimum overall score of the questionnaire is 0 and the maximum score is 105. A higher overall score on the Minnesota Living with Heart Failure Questionnaire indicates a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Baseline and 6 weeks

Results posted on

2020-04-03

Participant Flow

Participant milestones

Participant milestones
Measure
Low-intensity IMT Plus Walking
Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program consists of walking daily at an intensity of "somewhat hard" to "hard" on the Rating of Perceived Exertion scale. Participants are encouraged to walk 15 minutes twice a day, then progress to 45-50 minutes a day by six weeks. Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr
High-intensity IMT Plus Walking
Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking daily at an intensity of "somewhat hard" to "hard" on the Rating of Perceived Exertion scale. Participants are encouraged to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by six weeks. High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat har
Overall Study
STARTED
9
7
Overall Study
COMPLETED
3
5
Overall Study
NOT COMPLETED
6
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Low-intensity IMT Plus Walking
Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program consists of walking daily at an intensity of "somewhat hard" to "hard" on the Rating of Perceived Exertion scale. Participants are encouraged to walk 15 minutes twice a day, then progress to 45-50 minutes a day by six weeks. Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr
High-intensity IMT Plus Walking
Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking daily at an intensity of "somewhat hard" to "hard" on the Rating of Perceived Exertion scale. Participants are encouraged to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by six weeks. High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat har
Overall Study
transportation issues
2
1
Overall Study
relocation
1
0
Overall Study
readmission to a hospital
2
1
Overall Study
Lost to Follow-up
1
0

Baseline Characteristics

Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Low-intensity IMT Plus Walking
n=9 Participants
Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk at 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of the six weeks. Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr
High-intensity IMT Plus Walking
n=7 Participants
Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of six weeks. High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat har
Total
n=16 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
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
6 Participants
n=7 Participants
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Six-Minute Walk Test Distance
413.92 meters
STANDARD_DEVIATION 85 • n=5 Participants
356.00 meters
STANDARD_DEVIATION 85.3 • n=7 Participants
388 meters
STANDARD_DEVIATION 109 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks

This questionnaire includes 21 questions which ask how much the heart condition affected the patient's life during the past month. Each question has 5 optional answers with the scores ranging from 0 to 5. A higher score indicates a worse outcome. The minimum overall score of the questionnaire is 0 and the maximum score is 105. A higher overall score on the Minnesota Living with Heart Failure Questionnaire indicates a worse outcome.

Outcome measures

Outcome measures
Measure
Low-intensity IMT Plus Walking
n=3 Participants
For the low-intensity Inspiratory Muscle Training (IMT), the intensity was set at 15% maximal inspiratory pressure (PImax), which was considered "Sham training".. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. The IMT training is about 15-20 minutes. Both groups came to our facility once a week for 15 to 20 minutes for discussions about their progress and readjustment of the training intensity on the IMT breathing device.
High-intensity IMT Plus Walking
n=5 Participants
For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured..
Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score
MLHF score at baseline
36 score on a scale
Interval 11.0 to 66.0
57.6 score on a scale
Interval 48.0 to 92.0
Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score
change from baseline at 6 weeks
18.6 score on a scale
Interval -5.0 to 34.0
-20.6 score on a scale
Interval -53.0 to 27.0

PRIMARY outcome

Timeframe: Baseline and 6 weeks

The SF-36 quality of life questionnaire (short form) was used. A higher score of the SF-36 questionnaire indicates a better outcome (i.e., lower disability). The range of overall score on the SF-36 questionnaire is from 0 to 100.

Outcome measures

Outcome measures
Measure
Low-intensity IMT Plus Walking
n=3 Participants
For the low-intensity Inspiratory Muscle Training (IMT), the intensity was set at 15% maximal inspiratory pressure (PImax), which was considered "Sham training".. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. The IMT training is about 15-20 minutes. Both groups came to our facility once a week for 15 to 20 minutes for discussions about their progress and readjustment of the training intensity on the IMT breathing device.
High-intensity IMT Plus Walking
n=5 Participants
For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured..
Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire
Baseline Physical SF-36
34.1 score on a scale
Interval 21.8 to 49.1
30.7 score on a scale
Interval 23.4 to 40.4
Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire
Change from baseline physical SF-36
0.82 score on a scale
Interval -9.44 to 9.4
7.08 score on a scale
Interval 2.0 to 17.6

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Each subject was given a pedometer to record his/her step counts every day.

Outcome measures

Outcome measures
Measure
Low-intensity IMT Plus Walking
n=3 Participants
For the low-intensity Inspiratory Muscle Training (IMT), the intensity was set at 15% maximal inspiratory pressure (PImax), which was considered "Sham training".. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. The IMT training is about 15-20 minutes. Both groups came to our facility once a week for 15 to 20 minutes for discussions about their progress and readjustment of the training intensity on the IMT breathing device.
High-intensity IMT Plus Walking
n=5 Participants
For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured..
Mean Daily Step Counts From Week 1 to Week 6
Baseline daily step count at Week 1
3512 steps/day
Interval 1051.0 to 6386.0
7002 steps/day
Interval 4222.0 to 9095.0
Mean Daily Step Counts From Week 1 to Week 6
Daily step counts at week 6
4434 steps/day
Interval 1247.0 to 7798.0
9255 steps/day
Interval 4694.0 to 12173.0

SECONDARY outcome

Timeframe: Baseline and 6 weeks

The inspiratory muscle strength will be measured in the unit of cmH2O by the Respiratory Muscle Pressure Meter (Micro Direct). A higher inspiratory pressure indicates a better inspiratory breathing strength.

Outcome measures

Outcome measures
Measure
Low-intensity IMT Plus Walking
n=3 Participants
For the low-intensity Inspiratory Muscle Training (IMT), the intensity was set at 15% maximal inspiratory pressure (PImax), which was considered "Sham training".. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. The IMT training is about 15-20 minutes. Both groups came to our facility once a week for 15 to 20 minutes for discussions about their progress and readjustment of the training intensity on the IMT breathing device.
High-intensity IMT Plus Walking
n=5 Participants
For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured..
Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)
Baseline PImax at week 1
51.44 cm H2O
Interval 38.0 to 65.0
43.53 cm H2O
Interval 19.0 to 72.0
Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)
PImax at week 6
57.22 cm H2O
Interval 35.67 to 73.0
58.13 cm H2O
Interval 38.0 to 81.0

SECONDARY outcome

Timeframe: Baseline and 6 Weeks

The six-minute walk test is a measure of cardiovascular endurance which measures how far a person can walk in 6 minutes. This test was conducted twice respectively at pre-training and at post-training to account for potential learning effect. A longer distance walked on the six-minute walking test indicates a better cardiovascular endurance.

Outcome measures

Outcome measures
Measure
Low-intensity IMT Plus Walking
n=3 Participants
For the low-intensity Inspiratory Muscle Training (IMT), the intensity was set at 15% maximal inspiratory pressure (PImax), which was considered "Sham training".. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. The IMT training is about 15-20 minutes. Both groups came to our facility once a week for 15 to 20 minutes for discussions about their progress and readjustment of the training intensity on the IMT breathing device.
High-intensity IMT Plus Walking
n=5 Participants
For the high-intensity Inspiratory Muscle Training (IMT), the intensity is set at 60% maximal inspiratory pressure (PImax). Frequency: 5x/week; 1x/day preferred. 6 rest Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The walking program consisted of walking at an intensity of "hard" to "somewhat hard" on the Borg's Rating of Perceived Exertion scale. Participants were encouraged to walk at 15 minutes once to twice a day initially, then progress to a total of 45-50 minutes a day, if they could tolerate, by the end of six weeks. Every participant was given a pedometer and a polar heart rate monitor to track step counts and walking heart rate. Both groups returned once a week for discussions about their progress and readjustment of the IMT training intensity based on the new PImax measured..
Six-minute Walk Test Distance
six-minute walk distance at week 1
356.16 meters
Interval 241.8 to 507.72
378.04 meters
Interval 353.57 to 415.26
Six-minute Walk Test Distance
Six-minute walk distance at week 6
375.78 meters
Interval 232.61 to 585.22
419.71 meters
Interval 365.46 to 465.73

Adverse Events

Low-intensity IMT Plus Walking

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

High-intensity IMT Plus Walking

Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Low-intensity IMT Plus Walking
n=9 participants at risk
Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk at 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of the six weeks. Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr
High-intensity IMT Plus Walking
n=7 participants at risk
Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of six weeks. High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat har
Cardiac disorders
hospitalization
0.00%
0/9 • Six weeks
14.3%
1/7 • Number of events 1 • Six weeks
Respiratory, thoracic and mediastinal disorders
hospitalization
22.2%
2/9 • Number of events 2 • Six weeks
0.00%
0/7 • Six weeks

Other adverse events

Other adverse events
Measure
Low-intensity IMT Plus Walking
n=9 participants at risk
Inspiratory Muscle Training (IMT) intensity is set at 15% PImax. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk at 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of the six weeks. Low-intensity IMT plus walking: The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will begin walking at least 15 minutes twice a day for 7 days a week and eventually pr
High-intensity IMT Plus Walking
n=7 participants at risk
Inspiratory Muscle Training (IMT) intensity is set at 60% PImax. The walking program will consist of walking every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion (RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of six weeks. High-intensity IMT plus walking: The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. The walking program will consist of walking every day at an intensity of "hard" to "somewhat har
Cardiac disorders
transportation issue, relocation, loss to follow up
66.7%
6/9 • Number of events 6 • Six weeks
28.6%
2/7 • Number of events 2 • Six weeks

Additional Information

Dr. Suh-Jen Lin

Texas Woman's University

Phone: 214-689-7718

Results disclosure agreements

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