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

Not Applicable

Not yet recruiting

• Conditions: Hypokalemic Periodic Paralysis; Hyperkalemic Periodic Paralysis

• Registration Number: NCT07194174
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-10
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-01
• Primary Completion: 2026-10-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional endurance test in the form of the 6-Minute Walk Test (6MWT)	12 weeks
Number of attacks of muscle weakness	12 weeks	Self-reported by participants
Myotonia graded using the Myotonia Behaviour Scale (MBS)	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
Fatigue measured with the Multidimensional Fatigue Inventory (MFI-20)	12 weeks	A questionnaire consisting of 20 questions. The higher the collected score upon answering all the questions indicates a more severe fatigue.
Muscle strength measured with a dynamometer	12 weeks	Dynamometer used: Biodex
Pain graded using the Visual Analog Scale (VAS)	12 weeks	A pain scale from 0-10, where 0 is no pain and 10 is the worst pain possible
Quality of life measured with the Individualized Neuromuscular Quality of Life Questionnaire (INQoL)	12 weeks	To assess health-related quality of life of patient suffering from neuromuscular diseases.
Quality of life measured with the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L)	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.