Spinal and Bulbar Muscular AtrophyHIT in KennedyNCT02156141
High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
A study testing Supervised high intensity training, Optional training and Unsupervised High intensity training in people with Spinal and Bulbar Muscular Atrophy and Healthy Subjects, run by Karen Brorup Heje Pedersen at 1 site in Denmark.
Trial summary
We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal and Bulbar Muscular Atrophy, Healthy Subjects
- What is being tested?
- Supervised high intensity training, Optional training and Unsupervised High intensity training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to 1 Jun 2016
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with Spinal and bulbar muscular atrophy or
- Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.
Who cannot join
- More than 1 hour of fitness weekly before inclusion
- Other disease possibly confounding the results
- Pregnancy or breastfeeding
- Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion.
- Physical and/or mental conditions preventing participating in the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.
- Being tested
- Supervised high intensity training, Optional training, Control period, Unsupervised High intensity training
- Keywords
- Kennedy's disease, Spinal and bulbar muscular atrophy, High Intensity Training, High Intensity Interval Training, HIT, HIIT, Training, Exercise, 10-20-30
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised high intensity trainingOther
8 weeks of supervised training
Optional trainingOther
8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.
Control periodOther
8 weeks with no training.
Unsupervised High intensity trainingOther
8 weeks of unsupervised high intensity training.
| Study group | Role | What they receive |
|---|---|---|
| Supervised high intensity training | Experimental | 8 weeks of supervised high intensity training, 10 minutes, 3 times a week (once a week supervised) on a cycle ergometer followed by 8 weeks of unsupervised optional training.
Participants: Patients with Kennedy's disease or healthy control subjects (individually matched with patients).
Participants: Patients with Kennedys disease and healthy control subjects. Receives: Other: Supervised high intensity training; Other: Optional training |
| Unsupervised High intensity training | Experimental | 8 week control period with no training followed by 8 weeks of unsupervised high intensity training on a cycle ergometer.
Participants: Patients with Kennedy's disease. Receives: Other: Control period; Other: Unsupervised High intensity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental test
Primary outcome is changes from baseline in maximal oxygen consumption and maximal workload after a 8 week supervised training program followed by a 8 week non-supervised optional training period.
during and after 8 weeks of High Intensity Training on a cycle ergometer. The outcome is measured by an incremental test on a cycle ergometer.
Measured: Baseline, week 6, week 11, week 18
Secondary outcomes (4)
Functional test
Changes from baseline to end of training in muscle strength measured by handhold dynamometry, in 6 minute walk-test and in 5 time sit-to-stand test is secondary outcome.
Measured: Baseline, week 6, week 11, week 18.
Self-rated muscle fatigue, muscle pain and activity level
Self-rated muscle fatigue, muscle pain (VAS) and activity level is noted every day in diary in the two "run-in" weeks (baseline data) and thereafter every day in the 8 weeks training program. Changes from baseline is a secondary outcome.
Measured: Every day in week 1-11
Serum concentrations of Creatine Kinase (CK)
Serum concentrations of Creatine Kinase (CK) as a measurement of muscle damage. Blood samples are taken at every test day wich is the same for patient group 1 and healthy controls.
In patient group 2 blood samples are taken at baseline, week 6, week 11 and week 18-
Measured: Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.
Activity level
Activity levels are measured by using a pedometer for a week at baseline, week 10 and week 18. Changes from baseline is a secondary outcome.
Measured: Baseline, week 10 and week 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal and Bulbar Muscular AtrophyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Brorup Heje Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Brorup Heje Pedersen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156141
- Sponsor's protocol ID
- H-4-2014-035
- Acronym
- HIT in Kennedy
- Status last verified
- Feb 2018
- First submitted
- 4 Jun 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy
- ClinicalTrials.gov ID
- NCT02156141
- Acronym / sponsor ID
- HIT in Kennedy / H-4-2014-035
- Keywords
- Kennedy's disease, Spinal and bulbar muscular atrophy, High Intensity Training, High Intensity Interval Training, HIT, HIIT, Training, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karen Brorup Heje PedersenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 5 Jun 2014 (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.
We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised high intensity training | Experimental | Other: Supervised high intensity training, Other: Optional training8 weeks of supervised high intensity training, 10 minutes, 3 times a week (once a week supervised) on a cycle ergometer followed by 8 weeks of unsupervised optional training. Participants: Patients with Kennedy's disease or healthy control subjects (individually matched with patients). Participants: Patients with Kennedys disease and healthy control subjects. |
| Unsupervised High intensity training | Experimental | Other: Control period, Other: Unsupervised High intensity training8 week control period with no training followed by 8 weeks of unsupervised high intensity training on a cycle ergometer. Participants: Patients with Kennedy's disease. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Spinal and bulbar muscular atrophy or
- Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level.
Key exclusion criteria (5 listed)
- More than 1 hour of fitness weekly before inclusion
- Other disease possibly confounding the results
- Pregnancy or breastfeeding
- Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion.
- Physical and/or mental conditions preventing participating in the study protocol.
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 |
|---|---|---|
| Supervised high intensity training8 weeks of supervised training | Other | Supervised high intensity training |
| Optional training8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not. | Other | Supervised high intensity training |
| Control period8 weeks with no training. | Other | Unsupervised High intensity training |
| Unsupervised High intensity training8 weeks of unsupervised high intensity training. | Other | Unsupervised High intensity training |
Primary outcome
Incremental test
Time frame: Baseline, week 6, week 11, week 18
Primary outcome is changes from baseline in maximal oxygen consumption and maximal workload after a 8 week supervised training program followed by a 8 week non-supervised optional training period. during and after 8 weeks of High Intensity Training on a cycle ergometer. The outcome is measured by an incremental test on a cycle ergometer.
4 secondary outcomes
Functional test
Time frame: Baseline, week 6, week 11, week 18.
Self-rated muscle fatigue, muscle pain and activity level
Time frame: Every day in week 1-11
Serum concentrations of Creatine Kinase (CK)
Time frame: Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.
Activity level
Time frame: Baseline, week 10 and week 18.
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 5 Feb 2018.
- Website of Neuromuscular Research Unit, Rigshospitalet, Denmark.Link provided by the sponsor.
Related trials for Spinal and Bulbar Muscular Atrophy
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer
RecruitingPhase 3
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer
Prostate Cancer, mHSPC
Active, not recruitingPhase 2
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma
Salivary Gland Neoplasms
Active, not recruitingPhase 3
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Prostatic Neoplasms
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised high intensity training, Optional training and Unsupervised High intensity training in people with Spinal and Bulbar Muscular Atrophy and Healthy Subjects, run by Karen Brorup Heje Pedersen at 1 site in Denmark.
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 2 inclusion and 5 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 5 Feb 2018. 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 Denmark. 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?
Incremental test (time frame: Baseline, week 6, week 11, week 18). 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 5 Feb 2018.