Hypokalemic Periodic ParalysisNCT07194174
Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis
A study testing Strength exercise in people with Hypokalemic Periodic Paralysis and Hyperkalemic Periodic Paralysis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study wishes to investigate the effects of strength exercise in patients with either HypoPP or HyperPP. The investigators wishes to include participants already diagnosed with either HypoPP or HyperPP in af 24 week prospective study where the patients will be tested and asked to fill out questionnaires three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypokalemic Periodic Paralysis, Hyperkalemic Periodic Paralysis
- What is being tested?
- Strength exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with genetic verified HypoPP or HyperPP
- Age minimum 18 years
- Able to walk a minimum of 10 meters independently with or without assistive devices and be able to stand from a chair without using hands
Who cannot join
- Other significant cause of muscle weakness
- Heart or lung disease which, in the investigator's opinion, makes participation in the study training inadvisable
- Anticoagulant treatment
- Impaired blood clotting due to disease
- Metal implants in the body that contraindicate MRI scanning or are positioned such that the scan quality is significantly affected
- Claustrophobia
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, Copenhagen Neuromuscular Center
Copenhagen, 2100
John Vissing, Professor, +45 3545 6135, john.vissing@regionh.dk
About this study
This study wishes to investigate the effects of strength exercise in patients with either HypoPP or HyperPP.
The investigators wishes to include participants already diagnosed with either HypoPP or HyperPP in af 24 week prospective study where the patients will be tested and asked to fill out questionnaires three times. These appointments will be schedueled at week 0, week 12 and week 24.
In the time period between week 12 and week 24, the patients will have a personalized strength exercise program, which they will have to follow these 3 months. The exercise will be supervised by one or more of the investigators.
We will also assess the muscle structure and function cross sectionally.
- Being tested
- Strength exercise
- Medical subject headings
- Hypokalemic Periodic Paralysis, Paralysis, Hyperkalemic Periodic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength exerciseOther
3 weekly supervised trainings with specific strengt exercises
| Study group | Role | What they receive |
|---|---|---|
| Hypo-/HyperPP | Experimental | Strength exercise will be implemented for all participants included in this study. The first 12 weeks will be without intervention and after this period the intervention will begin. The participants are therefore all controls (no intervention) and experimental (intervention). Receives: Other: Strength exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional endurance test in the form of the Five Times Sit-to-Stand Test (5STS)
Measured: From intervention to end of intervention at 12 weeks
Secondary outcomes (13)
Functional endurance test in the form of the 6-Minute Walk Test (6MWT)
Measured: 12 weeks
Muscle strength measured with a dynamometer
Dynamometer used: Biodex
Measured: 12 weeks
Number of attacks of muscle weakness
Self-reported by participants
Measured: 12 weeks
Myotonia graded using the Myotonia Behaviour Scale (MBS)
Scale goes from 0-5, where 0 is no stiffness and 5 is incapacitating stiffness, which demands constant movement to not be totally locked up
Measured: 12 weeks
Quality of life measured with the Individualized Neuromuscular Quality of Life Questionnaire (INQoL)
To assess health-related quality of life of patient suffering from neuromuscular diseases.
Measured: 12 weeks
Quality of life measured with the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: 12 weeks
Fatigue measured with the Multidimensional Fatigue Inventory (MFI-20)
A questionnaire consisting of 20 questions. The higher the collected score upon answering all the questions indicates a more severe fatigue.
Measured: 12 weeks
Pain graded using the Visual Analog Scale (VAS)
A pain scale from 0-10, where 0 is no pain and 10 is the worst pain possible
Measured: 12 weeks
Fat fraction of leg muscles
Dixon MRI sequencing of leg muscles. Outcome: fat fraction. Is taken one time to describe the characteristics cross-sectionally.
Measured: 1 hour
Muscle biopsy
Muscle biopsies will be taken one time to describe the muscle phenotype cross-sectionally. We will look for structural changes, including vacoules.
Measured: 1 hour
Qualitative interview describing former and current experiences with exercise
After the exercise period, participants will be interviewed about their experiences with the exercise program and former exercise experiences, both personal and through the healthcare system.
Measured: 2 hours
Timed up and go (TUG)
We measure the time it takes to raise from a chair, walk 3 meters, turn around, walk back, and sit down. We assess it one time to measure the characteristics cross-sectionally.
Measured: 5 minutes
Sit to rise test (STR)
We measure number of times the participants can raise and sit from a chair in 10 seconds. We measure it one time to assess the characteristics cross-sectionally.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start2 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypokalemic Periodic ParalysisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annica Buss Enegaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194174
- Sponsor's protocol ID
- H-25003151
- Status last verified
- Mar 2026
- First submitted
- 10 Sep 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis
- ClinicalTrials.gov ID
- NCT07194174
- Acronym / sponsor ID
- H-25003151
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Sep 2025 (actual)
- 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 study wishes to investigate the effects of strength exercise in patients with either HypoPP or HyperPP.
The investigators wishes to include participants already diagnosed with either HypoPP or HyperPP in af 24 week prospective study where the patients will be tested and asked to fill out questionnaires three times. These appointments will be schedueled at week 0, week 12 and week 24.
In the time period between week 12 and week 24, the patients will have a personalized strength exercise program, which they will have to follow these 3 months. The exercise will be supervised by one or more of the investigators.
We will also assess the muscle structure and function cross sectionally.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypo-/HyperPP | Experimental | Other: Strength exerciseStrength exercise will be implemented for all participants included in this study. The first 12 weeks will be without intervention and after this period the intervention will begin. The participants are therefore all controls (no intervention) and experimental (intervention). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with genetic verified HypoPP or HyperPP
- Age minimum 18 years
- Able to walk a minimum of 10 meters independently with or without assistive devices and be able to stand from a chair without using hands
Key exclusion criteria (7 listed)
- Other significant cause of muscle weakness
- Heart or lung disease which, in the investigator's opinion, makes participation in the study training inadvisable
- Anticoagulant treatment
- Impaired blood clotting due to disease
- Metal implants in the body that contraindicate MRI scanning or are positioned such that the scan quality is significantly affected
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 |
|---|---|---|
| Strength exercise3 weekly supervised trainings with specific strengt exercises | Other | Hypo-/HyperPP |
Primary outcome
Functional endurance test in the form of the Five Times Sit-to-Stand Test (5STS)
Time frame: From intervention to end of intervention at 12 weeks
13 secondary outcomes
Functional endurance test in the form of the 6-Minute Walk Test (6MWT)
Time frame: 12 weeks
Muscle strength measured with a dynamometer
Time frame: 12 weeks
Number of attacks of muscle weakness
Time frame: 12 weeks
Myotonia graded using the Myotonia Behaviour Scale (MBS)
Time frame: 12 weeks
Quality of life measured with the Individualized Neuromuscular Quality of Life Questionnaire (INQoL)
Time frame: 12 weeks
Quality of life measured with the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: 12 weeks
Fatigue measured with the Multidimensional Fatigue Inventory (MFI-20)
Time frame: 12 weeks
Pain graded using the Visual Analog Scale (VAS)
Time frame: 12 weeks
Fat fraction of leg muscles
Time frame: 1 hour
Muscle biopsy
Time frame: 1 hour
Qualitative interview describing former and current experiences with exercise
Time frame: 2 hours
Timed up and go (TUG)
Time frame: 5 minutes
Sit to rise test (STR)
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength exercise in people with Hypokalemic Periodic Paralysis and Hyperkalemic Periodic Paralysis, run by Copenhagen University Hospital, Rigshospitalet 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annica B Enegaard (+4535456135, annica.buss.enegaard.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional endurance test in the form of the Five Times Sit-to-Stand Test (5STS) (time frame: From intervention to end of intervention at 12 weeks). 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 Mar 2026.