High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

Karen Brorup Heje Pedersen10 enrolled

Overview

We want investigate if high intensity training can increase daily functionality without causing muscle damage in patients Spinal and Bulbar Muscular Atrophy . We want to study if there is a difference in effect with supervised and unsupervised training. Furthermore we want to study if a supervised training program will motivate participants to continue training by the end of the program.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Spinal and Bulbar Muscular Atrophy Healthy Subjects

Interventions

Supervised high intensity trainingOTHER

8 weeks of supervised training

Optional trainingOTHER

8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.

Control periodOTHER

8 weeks with no training.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with Spinal and bulbar muscular atrophy or * Healthy control subjects matched individually with participating patients on age, sex, BMI and activity level. Exclusion Criteria: * More than 1 hour of fitness weekly before inclusion * Other disease possibly confounding the results * Pregnancy or breastfeeding * Participations in other scientific studies wich could influence on the results during the last 30 days before inclusion. * Physical and/or mental conditions preventing participating in the study protocol.

Locations (1)

Neuromuscular Research Unit

Copenhagen, Denmark

Outcomes

Primary Outcomes

Incremental test

Primary outcome is changes from baseline in maximal oxygen consumption and maximal workload after a 8 week supervised training program followed by a 8 week non-supervised optional training period. during and after 8 weeks of High Intensity Training on a cycle ergometer. The outcome is measured by an incremental test on a cycle ergometer.

Time frame: Baseline, week 6, week 11, week 18

Secondary Outcomes

Functional test

Changes from baseline to end of training in muscle strength measured by handhold dynamometry, in 6 minute walk-test and in 5 time sit-to-stand test is secondary outcome.

Time frame: Baseline, week 6, week 11, week 18.

Self-rated muscle fatigue, muscle pain and activity level

Self-rated muscle fatigue, muscle pain (VAS) and activity level is noted every day in diary in the two "run-in" weeks (baseline data) and thereafter every day in the 8 weeks training program. Changes from baseline is a secondary outcome.

Time frame: Every day in week 1-11

Serum concentrations of Creatine Kinase (CK)

Serum concentrations of Creatine Kinase (CK) as a measurement of muscle damage. Blood samples are taken at every test day wich is the same for patient group 1 and healthy controls. In patient group 2 blood samples are taken at baseline, week 6, week 11 and week 18-

Time frame: Baseline, Week 3,4,5,6,7,8,9,10,11, week 18.

Activity level

Activity levels are measured by using a pedometer for a week at baseline, week 10 and week 18. Changes from baseline is a secondary outcome.

Time frame: Baseline, week 10 and week 18.

Data from ClinicalTrials.gov

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