High-intensity Interval Training in Patients With Spinal Muscular Atrophy

NCT06368076 | Recruiting DMC

• 1 other identifier: H-23065096
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy.

Conditions

Spinal Muscular Atrophy

Keywords

Wheelchair cycle exercise

Outcome Measures

Primary Outcomes (5)

• Questionnaire on fatigue

  The Multidimensional Fatigue Inventory (MFI-20) will be used. It measures fatigue in 5 different domains comprised of 4 items each with values ranging from 1 to 5. A higher score indicates more fatigue. Each domain is scored individually, ranging from 4 points (best outcome) to 20 points (worst outcome).

  5 minutes

• Questionnaire on pain.

  A visual pain score for leg and lower back pain with 3 questions with scores ranging from 1 to 10 each, 10 being the worst pain imaginable, will be used.

  5 minutes

• Questionnaire on constipation

  A questionnaire made from the Danish definition of constipation will be used. Four questions will be answered "yes" or "no".

  5 minutes

• Questionnaire on quality of life

  A QoL that has been used in former studies will be used. 16 questions with scores ranging from 1 (very unsatisfied) to 7 (very satisfied) will be scored.

  10 minutes

• Questionnaire on sleep quality

  Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL \< 5 associated with good sleep quality TOTAL \> 5 associated with poor sleep quality Minimum Score = 0 (better); Maximum Score = 21 (worse) Interpretation: TOTAL \< 5 associated with good sleep quality TOTAL \> 5 associated with poor sleep quality Minimum score is 0, maximum score is 21. Total over 5 is associated with good sleep quality and under 5 associated with poor sleep quality.

  10 minutes

Secondary Outcomes (18)

• Blood sample

  2 minutes

• Blood sample

  2 minutes

• Blood sample

  2 minutes

• Blood sample

  2 minutes

• Blood sample

  2 minutes

Study Arms (1)

Exercise

EXPERIMENTAL

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

High intensity interval training on a bike or pedaltrainer from the wheelchair.

Exercise

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal muscular atrophy
• Age: over 15 years

You may not qualify if:

• Competing disorders (as arthritis) or other muscle disorders as well as heart- or lung related issues.
• Current psychiatric treatment
• Unable to use the cycle ergometer due to contractures

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John Vissing, prof. MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Frølich, stud.med

CONTACT

+ 45 3545 3561; sophia.vera.froelich.01@regionh.dk

Noémie Receveur, stud.med.

CONTACT

+45 3545 3561; noemie.anne-marie.receveur.03@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: Prof. MD.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: April 16, 2024
• Study Start: January 9, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

DK (1)