Cystic FibrosisNCT01759342
Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation
A study testing Aerobic exercise, Resistance exercise and Flexibility and postural exercise in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode… Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Aerobic exercise, Resistance exercise and Flexibility and postural exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2008
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 6 to 21 years
- admission for an acute Cystic fibrosis (CF) exacerbation
- forced expiratory volume in 1 s (FEV1) of < 60% of predicted at admission
Who cannot join
- medically unstable as deemed by the attending physician
- had completed both arms of the present study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmimgham
Birmingham, Alabama, 35233
About this study
Official title: The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.
Read the detailed description
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.
The experimental group will participate in the following regime:
Day 1 - Evaluation including standardized tests and measures: If Day 1 is a M,W, F, day 2 will constitute: aerobic exercise between 20-30 minutes based on patient tolerance using the appropriate RPE scale (13-15 on Borg with patients ages 13-21, and 6-8 on pictoral CERT with patients ages 6-12)to ensure correct intensity. Choices will include treadmill, stationary bike, game bike, or ambulating at varying intensities throughout hospital; Balance Activities: Standing on bosu ball while performing UE activity (throwing, catching with another ball, Frisbee, etc.). Standing on one leg or B LE's will be determined by patients currently level.
If Day 1 is a Tuesday or Thursday, day 2 will constitute: 5-10 minutes of aerobic activity at warm up level (11-13 on Borg, and 4-6 on PCERT)x resistance training for UE: biceps, triceps, lattisimus, rhomboids/mid-trap, thoracic expansion exercises, and other muscles based on patient needs; resistance training for LE: quadriceps, hamstrings, gluteals (especially maximus and medius), and other muscles depending on patient need, core and abdominal strengthening, Stretches for flexibility depending on the patients individual needs: Thoracic expansion stretches will be done with every pt. supine and sidelying. Stretches are held for 10 seconds and repeated 10 times, Hamstring stretches will be performed if pt unable to reach line with sit and reach test.
- Conditions
- Cystic Fibrosis
- Being tested
- Aerobic exercise, Resistance exercise, Flexibility and postural exercise, Balance exercise
- Keywords
- Cystic fibrosis; pulmonary exacerbation, exercise
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Resistance exerciseBehavioural
Flexibility and postural exerciseBehavioural
Balance exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive exercise program | Experimental | Moderate to high intensity aerobic, resistance, flexibility, posture and balance exercise program Receives: Behavioral: Aerobic exercise; Behavioral: Resistance exercise; Behavioral: Flexibility and postural exercise; Behavioral: Balance exercise |
| Usual care exercise | Active comparator | 30 minutes/day of self selected mode and intensity of aerobic exercise Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity following intervention of a comprehensive excercise training program
Measured: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Secondary outcomes (3)
Muscle strength and power following intervention of a comprehensive excercise training program
Assessed with arm curl test, partial curl up test, timed 10 repetition sit to stand test
Measured: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Posture/flexibility following intervention of a comprehensive excercise training program
Assessed with humeral distance, shoulder flexion range of motion, and hamstring length
Measured: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Balance following intervention of a comprehensive excercise training program
Assessed with the pediatric Berg balance scale
Measured: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startApr 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John D Lowman, PT, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759342
- Sponsor's protocol ID
- 12.21.2012
- Status last verified
- Dec 2012
- First submitted
- 21 Dec 2012
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01759342
- Acronym / sponsor ID
- 12.21.2012
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis; pulmonary exacerbation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 3 Jan 2013 (estimated)
- 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.
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.
Detailed description
This protocol was designed to assess if when subjects with CF are admitted to the hospital for a pulmonary exacerbation if a comprehensive exercise program (moderate to high intensity aerobic, resistance, flexibility and balance exercises) was superior to our "usual care intervention (30 min/day of self selected mode and intensity of exercise) in improving aerobic capacity, muscle strength/power, flexibility and balance.
The experimental group will participate in the following regime:
Day 1 - Evaluation including standardized tests and measures: If Day 1 is a M,W, F, day 2 will constitute: aerobic exercise between 20-30 minutes based on patient tolerance using the appropriate RPE scale (13-15 on Borg with patients ages 13-21, and 6-8 on pictoral CERT with patients ages 6-12)to ensure correct intensity. Choices will include treadmill, stationary bike, game bike, or ambulating at varying intensities throughout hospital; Balance Activities: Standing on bosu ball while performing UE activity (throwing, catching with another ball, Frisbee, etc.). Standing on one leg or B LE's will be determined by patients currently level.
If Day 1 is a Tuesday or Thursday, day 2 will constitute: 5-10 minutes of aerobic activity at warm up level (11-13 on Borg, and 4-6 on PCERT)x resistance training for UE: biceps, triceps, lattisimus, rhomboids/mid-trap, thoracic expansion exercises, and other muscles based on patient needs; resistance training for LE: quadriceps, hamstrings, gluteals (especially maximus and medius), and other muscles depending on patient need, core and abdominal strengthening, Stretches for flexibility depending on the patients individual needs: Thoracic expansion stretches will be done with every pt. supine and sidelying. Stretches are held for 10 seconds and repeated 10 times, Hamstring stretches will be performed if pt unable to reach line with sit and reach test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive exercise program | Experimental | Behavioral: Aerobic exercise, Behavioral: Resistance exercise, Behavioral: Flexibility and postural exercise, Behavioral: Balance exerciseModerate to high intensity aerobic, resistance, flexibility, posture and balance exercise program |
| Usual care exercise | Active comparator | Behavioral: Aerobic exercise30 minutes/day of self selected mode and intensity of aerobic exercise |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 6 to 21 years
- admission for an acute Cystic fibrosis (CF) exacerbation
- forced expiratory volume in 1 s (FEV1) of < 60% of predicted at admission
Key exclusion criteria (2 listed)
- medically unstable as deemed by the attending physician
- had completed both arms of the present study
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 |
|---|---|---|
| Aerobic exercise | Behavioural | Comprehensive exercise program, Usual care exercise |
| Resistance exercise | Behavioural | Comprehensive exercise program |
| Flexibility and postural exercise | Behavioural | Comprehensive exercise program |
| Balance exercise | Behavioural | Comprehensive exercise program |
Primary outcome
Aerobic capacity following intervention of a comprehensive excercise training program
Time frame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
3 secondary outcomes
Muscle strength and power following intervention of a comprehensive excercise training program
Time frame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Posture/flexibility following intervention of a comprehensive excercise training program
Time frame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
Balance following intervention of a comprehensive excercise training program
Time frame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)
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 30 Jun 2015.
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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.
John D Lowman, PT, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Resistance exercise and Flexibility and postural exercise in people with Cystic Fibrosis, run by University of Alabama at Birmingham 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 3 inclusion and 2 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 30 Jun 2015. 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. 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?
Aerobic capacity following intervention of a comprehensive excercise training program (time frame: Participants will be followed for the duration of hospital stay, average number of days 10 (range 4 - 20 days)). 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 30 Jun 2015.