NCT05036447

Brief Summary

The purpose of this study is to investigate the response after one bout of moderate-heavy resistance exercise in patients suffering from Myotonic Dystrophy type 1. There is still doubt about if these patients could benefit from resistance exercise, or if this mode of exercise is detrimental to their mobility and health. We aim to monitor the subjects during the recovery phase and investigate recovery in several ways.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

May 10, 2021

Last Update Submit

November 27, 2023

Conditions

Myotonic Dystrophy 1

Keywords

Resistance exerciseRecoveryMuscle protein synthesisMuscle protein breakdownMuscle function

Outcome Measures

Primary Outcomes (1)

  • Change in muscle strength

    Recovery of knee extension torque

    Baseline, and 5 minutes, 3 hours, 24 hours, 48 hours, and 71 hours after exercise

Secondary Outcomes (2)

  • Muscle protein synthesis rate

    Baseline and 27 hours after final session of resistance exercise

  • Muscle protein breakdown rate

    Baseline and 27 hours after final session of resistance exercise

Other Outcomes (16)

  • Change in muscle damage

    Baseline and 27 hours after final session of resistance exercise

  • Change in muscle regeneration

    Baseline and 27 hours after final session of resistance exercise

  • Change in calcium cycling

    Baseline and 27 hours after final session of resistance exercise

  • +13 more other outcomes

Study Arms (4)

DM1-Ex

EXPERIMENTAL

Moderate-heavy resistance exercise of one leg in DM1-patients

Other: Moderate-Heavy Resistance Exercise

DM1-Rest

NO INTERVENTION

Control leg (i.e. no exercise) in DM1-patients

Ctrl-Ex

EXPERIMENTAL

Moderate-heavy resistance exercise of one leg in healthy participants

Other: Moderate-Heavy Resistance Exercise

Ctrl-Rest

NO INTERVENTION

Control leg (i.e. no exercise) in healthy participants

Interventions

Moderate-Heavy Resistance ExerciseOTHER

Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets. Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets.

Ctrl-ExDM1-Ex

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed Myotonic Dystrophy type 1-diagnosis

You may not qualify if:

  • Non-ambulatory
  • Injuries to muscle-skeletal-system that prevents resistance exercise
  • Severe affection of the cardiovascular system
  • Cognitive affection
  • Lives more than one hour from test site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0863, Norway

Location

MeSH Terms

Conditions

Myotonic Dystrophy

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesMyotonic DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Truls Raastad, PhD

    Norwegian School of Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Participants in both groups (patients and control) perform unilateral leg resistance exercise, contralateral leg serves as control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2021

First Posted

September 5, 2021

Study Start

June 14, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)