High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy (HIT in Kennedy)

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 Overview

• Status: Completed
• Conditions: Healthy Subjects; Spinal and Bulbar Muscular Atrophy
• Intervention / Treatment: Other: Supervised high intensity training; Other: Optional training; Other: Control period; Other: Unsupervised High intensity training

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Neuromuscular Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised high intensity training; 8 weeks of supervised high intensity training, 10 minutes, 3 times a week (once a week supervised) on a cycle ergometer followed by 8 weeks of unsupervised optional training. Participants: Patients with Kennedy's disease or healthy control subjects (individually matched with patients). Participants: Patients with Kennedys disease and healthy control subjects.	Other: Supervised high intensity training; 8 weeks of supervised training; Other: Optional training; 8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.
Experimental: Unsupervised High intensity training; 8 week control period with no training followed by 8 weeks of unsupervised high intensity training on a cycle ergometer. Participants: Patients with Kennedy's disease.	Other: Control period; 8 weeks with no training.; Other: Unsupervised High intensity training; 8 weeks of unsupervised high intensity training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, week 6, week 11, week 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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-	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.	Baseline, week 10 and week 18.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IGF-1	Changes in serum IGF-1 from baseline to week 11 and 18.	Baseline, week 11, week 18.

Collaborators and Investigators

• Sponsor: Karen Brorup Heje Pedersen

Publications and helpful links

Helpful Links

• Website of Neuromuscular Research Unit, Rigshospitalet, Denmark.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Training; Exercise; HIT; High Intensity Interval Training; HIIT; Kennedy's disease; Spinal and bulbar muscular atrophy; High Intensity Training; 10-20-30
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Motor Neuron Disease; Muscular Atrophy, Spinal; Muscular Atrophy; Atrophy; Bulbo-Spinal Atrophy, X-Linked
• Other Study ID Numbers: H-4-2014-035