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Exercise Training as Medicine for Substance Use Disorder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065334
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : March 18, 2020
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
This study compares the effects of high dose and low dose, high intensity, endurance training and strength training in substance use disorder patients. The hypothesis is that the increase in endurance (measured as maximal oxygen uptake) and strength (measured as maximal strength) will be similar in both the high dose and low dose training groups after 24 training sessions over eight weeks. The rationale for this assumption is based on the patient groups poor physical capacity, supporting that a lesser physical workload is needed to achieve a substantial increase in physical capacity. The practical implication could be higher training attendance, because it is likely easier to motivate the patient group when they only have to perform half the workload. It is paramount for this patient group to increase their physical capacity and consequently augment their physical health status since they are in a high-risk group for developing life-threatening lifestyle related diseases.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: High dose training Behavioral: low dose training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Low- Versus High Dose High Intensity Interval Training and Strength Training on Physical Health in Substance Use Disorder Patients: A Randomized Controlled Trial
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: low dose training Behavioral: low dose training
1 x 4 minutes of high intensity workload on treadmill and 2 repetitions x 4 sets of high intensity workload in hack squat

Active Comparator: high dose training Behavioral: High dose training
4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat




Primary Outcome Measures :
  1. change in oxygen uptake [ Time Frame: baseline to 8 weeks ]
    cardiopulmonary exercise test (CPET) objective gas measurements

  2. change in leg muscular strength [ Time Frame: baseline to 8 weeks ]
    One repetition maximum strength test half squat



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being an inpatient at the clinic
  • Free of known cardiovascular disease, pulmonary disease and cancer

Exclusion Criteria:

  • Not able to perform a maximal treadmill test
  • Not able to perform a maximal strength test in hack squat

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065334


Contacts
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Contact: Henrik Loe, phd 0047 92093611 henrik.loe@stolav.no
Contact: Grete Flemmen, phd grete.flemmen@stolav.no

Locations
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Norway
Klinikk for rus- og avhengighetsmedisin, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Henrik Loe, phd       henrik.loe@stoloav.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Kristin Smedsrud St. Olavs Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT04065334    
Other Study ID Numbers: 2019/502
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Resistance training
Endurance training
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders