Substance Abuse DisorderNCT06809504
To Assess the Effectiveness of Structured Occupational Therapy (OT) Interventions on Patients With SUD in Inpatient Department (IPD) Settings, Focusing on Improvements in Cognitive, Physical, and Functional Domains
A study testing Exercise based intervention in people with Substance Abuse Disorder, run by Hammad Mursaleen at 1 site in Pakistan.
Trial summary
OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Substance Abuse Disorder
- What is being tested?
- Exercise based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Apr 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Substance abused disorder
- Admitted in rehabilitation center
Who cannot join
- Severe cognitive impairment
- Physical disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Functionality: Occupational Therapy Interventions in Substance Use Drug Rehabilitation
OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Benefitting from checklists like the Montreal Cognitive Assessment (MoCA), the Barthel Index, the Lawton-Brody IADLs scale, it substantiates attaining enhancements in expressive cognitive functions, ADLs, and IADLs to understand how selected OT intervention modalities can enhance functional capabilities.
- Conditions
- Substance Abuse Disorder
- Being tested
- Exercise based intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise based interventionBehavioural
12 sessions over 4 weeks, 45-minute sessions divided into:
- 15 minutes for physical exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Exercise based intervention was given for 12 sessions over 4 weeks, 45-minute sessions Receives: Behavioral: Exercise based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA):
The MoCA offers assessment of many cognitive aspects, it presents assessments for attention, memory, language, visual construction, executive functions, and orientation.
Measured: baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start14 Apr 2024
- Primary completion12 Nov 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12 sessions over 4 weeks, 45-minute sessions divided into: * 15 minutes for physical exercises * 15 minutes for psychoeducation * 15 minutes for cognitive tasks and routine planning
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hammad Mursaleen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hammad Mursaleen, Foundation of Medical Research and Laboratories, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809504
- Sponsor's protocol ID
- FMRL01
- Other IDs
- FMRL01
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Functionality: Occupational Therapy Interventions in Substance Use Drug Rehabilitation
- ClinicalTrials.gov ID
- NCT06809504
- Acronym / sponsor ID
- FMRL01
- Conditions
- Substance Abuse Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hammad MursaleenUniversity, hospital or other
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OT emphasis lies within the scope of improving daily life activities, cognitive and physical performance in order to regain the proper social role. This work assesses the impact of a 12 session structured OT intervention program for patients with SUD in IPD. Benefitting from checklists like the Montreal Cognitive Assessment (MoCA), the Barthel Index, the Lawton-Brody IADLs scale, it substantiates attaining enhancements in expressive cognitive functions, ADLs, and IADLs to understand how selected OT intervention modalities can enhance functional capabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 sessions over 4 weeks, 45-minute sessions divided into: * 15 minutes for physical exercises * 15 minutes for psychoeducation * 15 minutes for cognitive tasks and routine planning
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Exercise based interventionExercise based intervention was given for 12 sessions over 4 weeks, 45-minute sessions |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Substance abused disorder
- Admitted in rehabilitation center
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- Physical disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise based intervention12 sessions over 4 weeks, 45-minute sessions divided into: o 15 minutes for physical exercises | Behavioural | Experimental Group |
Primary outcome
Montreal Cognitive Assessment (MoCA):
Time frame: baseline and after 12 weeks of intervention
The MoCA offers assessment of many cognitive aspects, it presents assessments for attention, memory, language, visual construction, executive functions, and orientation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise based intervention in people with Substance Abuse Disorder, run by Hammad Mursaleen at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA): (time frame: baseline and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.