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

Karen Brorup Heje Pedersen

Status: Completed

Conditions: Healthy Subjects; Spinal and Bulbar Muscular Atrophy

Treatments: Other: Optional training; Other: Control period; Other: Unsupervised High intensity training; Other: Supervised high intensity training

Study type: Interventional

Funder types: Other

Identifiers

NCT02156141

H-4-2014-035

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Supervised high intensity training

Experimental group

Description:

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.

Treatment:

Other: Supervised high intensity training

Other: Optional training

Unsupervised High intensity training

Experimental group

Description:

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.

Treatment:

Other: Unsupervised High intensity training

Other: Control period