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NCT Number: NCT07194174

Effect of Physical Training in Individuals With Hypokalemic and Hyperkalemic Periodic Paralysis

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.

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Key information

Conditions

Hypokalemic Periodic Paralysis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hyperkalemic Periodic Paralysis Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Paralyses, Familial Periodic Paralysis, Hyperkalemic Periodic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, Copenhagen Neuromuscular Center

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

John Vissing, Professor

CONTACT

[email protected]

+45 3545 6135

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength exercise

Other

3 weekly supervised trainings with specific strengt exercises

Primary outcomes

  1. 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 outcomes

  1. Functional endurance test in the form of the 6-Minute Walk Test (6MWT)

    Time frame: 12 weeks

  2. Muscle strength measured with a dynamometer

    Time frame: 12 weeks

    Dynamometer used: Biodex

  3. Number of attacks of muscle weakness

    Time frame: 12 weeks

    Self-reported by participants

  4. Myotonia graded using the Myotonia Behaviour Scale (MBS)

    Time frame: 12 weeks

    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

  5. Quality of life measured with the Individualized Neuromuscular Quality of Life Questionnaire (INQoL)

    Time frame: 12 weeks

    To assess health-related quality of life of patient suffering from neuromuscular diseases.

  6. Quality of life measured with the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)

    Time frame: 12 weeks

    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.

  7. Fatigue measured with the Multidimensional Fatigue Inventory (MFI-20)

    Time frame: 12 weeks

    A questionnaire consisting of 20 questions. The higher the collected score upon answering all the questions indicates a more severe fatigue.

  8. Pain graded using the Visual Analog Scale (VAS)

    Time frame: 12 weeks

    A pain scale from 0-10, where 0 is no pain and 10 is the worst pain possible

  9. Fat fraction of leg muscles

    Time frame: 1 hour

    Dixon MRI sequencing of leg muscles. Outcome: fat fraction. Is taken one time to describe the characteristics cross-sectionally.

  10. Muscle biopsy

    Time frame: 1 hour

    Muscle biopsies will be taken one time to describe the muscle phenotype cross-sectionally. We will look for structural changes, including vacoules.

  11. Qualitative interview describing former and current experiences with exercise

    Time frame: 2 hours

    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.

  12. Timed up and go (TUG)

    Time frame: 5 minutes

    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.

  13. Sit to rise test (STR)

    Time frame: 5 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annica B Enegaard

CONTACT

[email protected]

+4535456135

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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