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

NCT07194174 | Recruiting DMC

• 1 other identifier: H-25003151
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypokalemic Periodic Paralysis; Hyperkalemic Periodic Paralysis

Outcome Measures

Primary Outcomes (1)

• Functional endurance test in the form of the Five Times Sit-to-Stand Test (5STS)

  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)

  12 weeks

• Muscle strength measured with a dynamometer

  12 weeks

• Number of attacks of muscle weakness

  12 weeks

• Myotonia graded using the Myotonia Behaviour Scale (MBS)

  12 weeks

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

  12 weeks

Study Arms (1)

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).

Other: Strength exercise

Interventions

Strength exercise OTHER

3 weekly supervised trainings with specific strengt exercises

Hypo-/HyperPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Copenhagen Neuromuscular Center

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Hypokalemic Periodic Paralysis; Paralysis, Hyperkalemic Periodic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Annica B Enegaard

CONTACT

+4535456135; annica.buss.enegaard.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 26, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)