Back to resultsExercise Training as Medicine for Substance Use Disorder Patients
Primary Purpose
Substance Use Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High dose training
low dose training
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring Resistance training, Endurance training
Eligibility 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
Sites / Locations
- Klinikk for rus- og avhengighetsmedisin, St Olavs HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
low dose training
high dose training
Arm Description
Outcomes
Primary Outcome Measures
change in oxygen uptake
cardiopulmonary exercise test (CPET) objective gas measurements
change in leg muscular strength
One repetition maximum strength test half squat
Secondary Outcome Measures
Full Information
NCT ID
NCT04065334
First Posted
August 21, 2019
Last Updated
January 11, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04065334
Brief Title
Exercise Training as Medicine for Substance Use Disorder Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Resistance training, Endurance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low dose training
Arm Type
Experimental
Arm Title
high dose training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
High dose training
Intervention Description
4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat
Intervention Type
Behavioral
Intervention Name(s)
low dose training
Intervention Description
1 x 4 minutes of high intensity workload on treadmill and 2 repetitions x 4 sets of high intensity workload in hack squat
Primary Outcome Measure Information:
Title
change in oxygen uptake
Description
cardiopulmonary exercise test (CPET) objective gas measurements
Time Frame
baseline to 8 weeks
Title
change in leg muscular strength
Description
One repetition maximum strength test half squat
Time Frame
baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Loe, phd
Phone
0047 92093611
Email
henrik.loe@stolav.no
First Name & Middle Initial & Last Name or Official Title & Degree
Grete Flemmen, phd
Email
grete.flemmen@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Smedsrud
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Klinikk for rus- og avhengighetsmedisin, St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Loe, phd
Email
henrik.loe@stoloav.no
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36167363
Citation
Loe H, Mosti MP, Wisloff U, Haberstroh C, Flemmen G. Cardiopulmonary and muscular effects of different doses of high-intensity physical training in substance use disorder patients: study protocol for a block allocated controlled endurance and strength training trial in an inpatient setting. BMJ Open. 2022 Sep 27;12(9):e061014. doi: 10.1136/bmjopen-2022-061014.
Results Reference
derived
Learn more about this trial
Exercise Training as Medicine for Substance Use Disorder Patients
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