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

N/ANot Yet RecruitingNCT07194174

Rigshospitalet, Denmark36 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypokalemic Periodic Paralysis Hyperkalemic Periodic Paralysis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Time frame: 12 weeks

Muscle strength measured with a dynamometer

Dynamometer used: Biodex

Time frame: 12 weeks

Number of attacks of muscle weakness

Self-reported by participants

Time frame: 12 weeks

Myotonia graded using the Myotonia Behaviour Scale (MBS)

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

Time frame: 12 weeks

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

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

Time frame: 12 weeks

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

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.

Time frame: 12 weeks

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

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

Time frame: 12 weeks

Pain graded using the Visual Analog Scale (VAS)

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

Time frame: 12 weeks

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts