Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Strength exercise.
- Who it may be relevant to
- Registry conditions: Hypokalemic Periodic Paralysis, Hyperkalemic Periodic Paralysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Strength exercise
3 weekly supervised trainings with specific strengt exercises
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet, Copenhagen Neuromuscular Center — Copenhagen
Identifiers
NCT: NCT07194174 · H-25003151