High Intensity Training in Patients With Spinal and Bulbar Muscular Atrophy

NCT ID: NCT02156141

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal and Bulbar Muscular Atrophy Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supervised high intensity training

Intervention Type OTHER

8 weeks of supervised training

Optional training

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Control period

Intervention Type OTHER

8 weeks with no training.

Unsupervised High intensity training

Intervention Type OTHER

8 weeks of unsupervised high intensity training.

Interventions

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Supervised high intensity training

8 weeks of supervised training

Intervention Type 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.

Intervention Type OTHER

Control period

8 weeks with no training.

Intervention Type OTHER

Unsupervised High intensity training

8 weeks of unsupervised high intensity training.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karen Brorup Heje Pedersen

OTHER

Sponsor Role lead

Responsible Party

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Karen Brorup Heje Pedersen

Bachelor in medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Neuromuscular Research Unit

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.neuromuscular.dk

Website of Neuromuscular Research Unit, Rigshospitalet, Denmark.

Other Identifiers

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H-4-2014-035

Identifier Type: -

Identifier Source: org_study_id

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