Personalized strength training for adults with hypokalemic or hyperkalemic periodic paralysis
Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis
NA · Rigshospitalet, Denmark · NCT07194174
This study will try a 12-week personalized, supervised strength-training program for adults with genetically confirmed hypokalemic or hyperkalemic periodic paralysis to see if muscle strength and structure improve.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07194174 on ClinicalTrials.gov |
What this trial studies
This is a 24-week prospective study with clinical testing and questionnaires at baseline, 12 weeks, and 24 weeks. Between weeks 12 and 24 participants follow a personalized strength-exercise program supervised by study investigators. The protocol includes assessments of muscle structure and function, along with patient-reported outcomes. Eligible participants are adults with genetically confirmed HypoPP or HyperPP who can ambulate independently and stand from a chair without using their hands.
Who should consider this trial
Good fit: Adults (≥18 years) with genetically confirmed hypokalemic or hyperkalemic periodic paralysis who can walk at least 10 meters independently and can rise from a chair without using their hands.
Not a fit: Patients with other significant causes of muscle weakness, unstable heart or lung disease that make exercise unsafe, or those unable to complete supervised training are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could increase muscle strength and functional mobility and potentially reduce the frequency or severity of paralysis episodes.
How similar studies have performed: Small case series and exercise programs for neuromuscular channelopathies suggest safety and possible benefit, but there is limited high-quality evidence specifically in periodic paralysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Other significant cause of muscle weakness * Heart or lung disease which, in the investigator's opinion, makes participation in the study training inadvisable Exclusion from muscle biopsy * Anticoagulant treatment * Impaired blood clotting due to disease Exclusion from MRI scanning due to: * Metal implants in the body that contraindicate MRI scanning or are positioned such that the scan quality is significantly affected * Claustrophobia * Pregnancy
Where this trial is running
Copenhagen
- Rigshospitalet, Copenhagen Neuromuscular Center — Copenhagen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Annica B Enegaard
- Email: annica.buss.enegaard.01@regionh.dk
- Phone: +4535456135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypokalemic Periodic Paralysis, Hyperkalemic Periodic Paralysis