NCT04065334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

August 21, 2019

Last Update Submit

June 4, 2025

Conditions

Keywords

Resistance trainingEndurance training

Outcome Measures

Primary Outcomes (2)

  • change in oxygen uptake

    cardiopulmonary exercise test (CPET) objective gas measurements

    baseline to 8 weeks

  • change in leg muscular strength

    One repetition maximum strength test half squat

    baseline to 8 weeks

Study Arms (2)

low dose training

EXPERIMENTAL
Behavioral: low dose training

high dose training

ACTIVE COMPARATOR
Behavioral: High dose training

Interventions

4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat

high 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

low dose training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikk for rus- og avhengighetsmedisin, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Kristin Smedsrud

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 22, 2019

Study Start

February 1, 2020

Primary Completion

December 11, 2023

Study Completion

December 11, 2023

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations