Group-based Resistance Training for Adults With Down Syndrome

NCT ID: NCT07347912

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-08-01

Brief Summary

The investigators are interested in Resistance Training as a physical exercise intervention for adults with Down syndrome. Resistance Training (or RT for short) is a popular form of physical exercise, which focuses on improving muscle strength and endurance using weighted or resistance-based exercises. RT can involve 'lifting weights', doing resistance band movements or performing bodyweight exercises. Researchers have developed a tailored programme of RT exercises (called RESID), which are suitable and safe to implement for individuals with mild to moderate intellectual disabilities. RT has been shown to help people improve thinking skills and overall quality of life. RT has been associated with better brain health in older adults with memory problems. The investigators want to run the RESID exercise programme with adults with Down syndrome who do not have memory problems but who the investigators know are at much greater risk of developing memory problems as they get older. The investigators are hoping this programme will support brain health and healthy ageing in adults with Down syndrome. The investigators want to see this programme can be successfully run with people with intellectual disabilities. The investigators want to see if participants enjoy this programme and engage well with it. The investigators want to see if there are any barriers to participating in this programme. The investigators also want to see how much it will cost to run this programme again in the future. The investigators also want to see if this programme helps these adults to feel better about themselves, to have better memory skills, to have better day-to-day skills, and to have better strength and mobility. The investigators will measure study outcomes using self-report scales, a memory assessment, strength test, mobility tests, blood pressure/heart rate test and by getting information from caregivers. The investigators will use the same measures with a similar group of adults who initially do not take part in this programme. They will be called our services as usual control group. During the first group, these adults will attend usual weekly services. However, they will be offered a place on a RT programme after the first experimental group have finished. The investigators will decide the order of who takes part in which initial group (Experimental or Control) by drawing names out of a hat so that it will be as fair as possible. However, all participants in this study will eventually take part in the RT programme. The investigators hope this study will tell us a lot about running a RT programme for people with intellectual disabilities. The investigators hope the results of this research study will show that adults with Down syndrome enjoy and engage well with this programme and that RT has benefits for adults with Down syndrome who do not memory problems. The investigators hope to show that RT can support the healthy ageing of adults with Down syndrome.

Detailed Description

The proposed study intends to measure the feasibility and efficacy of a standardised group-based resistance training (RT) exercise program for adults with an intellectual disability (ID) at high risk of developing Alzheimer's disease (AD) in the future. Adults with Down syndrome (DS) are at "ultra-high" risk of developing AD as they age. However, there is a dearth of research studies focusing on brain health strategies for this population. Physical activity (PA) is emerging as key brain health booster. PA has been shown to affect brain plasticity influencing both cognition and well-being. Encouragingly, there is emerging evidence that PA can boost cognitive reserve in adults with DS. RT is a popular form of physical exercise, which focuses on improving muscle strength using weighted or resistance-based exercises. RT has been shown to be an important dementia risk-reduction strategy for adults in the general population. A standardised resistance exercise set for a total body workout for adults with mild or moderate intellectual disabilities (RESID) has recently been developed. The current research will focus on evaluating the benefits of this RESID programme for adults with DS who are at "ultra-high" risk of developing AD in the future. The study will be conducted as a pilot randomised control crossover trial with all participants eventually receiving the RT intervention. Study results will contribute significantly to our understanding of the impact of proactive RT on key health and well-being outcomes for adults with Down Syndrome.

The information collected in this study will be limited to the information that is needed to answer the research study questions. With the consent of participants, the investigators will seek to place some of the assessment information on participants' Clinical (Psychology) File. This information will be important for the person if there are concerns about memory/cognitive skills in the future. This information will be stored safely on the Psychology File and will only be accessed by the Psychology Team. The investigators will also seek to deposit the anonymous data from this study in a secure anonymous data register for future research projects but only where these projects are approved by a Research Ethics Committee. With the participants' consent, the investigators will seek to deposit an anonymous data file derived from this study in a secure anonymous future Saint John of God Data register by the year 2034 to be used for future research projects but only where these projects are approved by a Research Ethics Committee. This data register has not yet been built but the investigators want to fully inform the potential participants of what will happen to the anonymous data derived from personal data.

Conditions

Down Syndrome; Healthy Aging; Resistance Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Resistance Training

Individuals in this group will initially attend the 12-week (24 session) RT programme. They will also attend assessment sessions at baseline, post-programme and three-month follow-up. After the crossover, the experimental group will receive their services as usual and attend the remaining assessment sessions (post-programme; three-month follow-up) as control participants.

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: BEHAVIORAL

Resistance Training (or RT for short) is a popular form of physical exercise, which focuses on improving muscle strength and endurance using weighted or resistance-based exercises.

RT can involve 'lifting weights', doing resistance band movements or performing bodyweight exercises.

Services as Usual Control Group

Individuals in the services as usual control group will initially attend their services as usual for 12 weeks. They will also attend assessment sessions at baseline, post-programme and three-month follow-up. After the crossover, the services as usual control group will receive the 12-week (24 session) RT programme and will attend remaining assessment sessions (post-programme; three-month follow-up) as experimental participants.

Group Type: OTHER

Services as Usual Control Group

Intervention Type: OTHER

Participants will receive services as usual for the initial 12-week period prior to crossover to the resistance training intervention. During Period 2 (12 weeks), participants initially assigned to the resistance training group return to services as usual control group.

Interventions

Resistance Training

Resistance Training (or RT for short) is a popular form of physical exercise, which focuses on improving muscle strength and endurance using weighted or resistance-based exercises.

RT can involve 'lifting weights', doing resistance band movements or performing bodyweight exercises.

Intervention Type: BEHAVIORAL

Services as Usual Control Group

Participants will receive services as usual for the initial 12-week period prior to crossover to the resistance training intervention. During Period 2 (12 weeks), participants initially assigned to the resistance training group return to services as usual control group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants:

• Previous diagnosis of Down Syndrome;
• Previous diagnosis of Mild to Moderate Intellectual Disability;
• Aged between 20 to 45 years old;
• Capable of providing consent to participate in this research study;
• Have a close caregiver (proxy participant) who also consents to take part in this study.

Proxy:

• Be a close caregiver (family or staff) for a participant;
• Consent to participate in this research study.

Exclusion Criteria

Participants:

• Severe or Profound Intellectual Disability;
• Significant behaviours of concern that would preclude group participation;
• Showing signs of dementia at pre-screening (on the G-DSDS);
• does not have a close caregiver who consents to take part in this study.

Proxy:

• none

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Dublin

OTHER

Sponsor Role: collaborator

Saint John of God Intellectual Disability Services - Dublin South East

OTHER

Sponsor Role: lead

Responsible Party

Sharon Hardiman

Senior Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon Hardiman

Role: PRINCIPAL_INVESTIGATOR

Saint John of God Intellectual Disability Services - Dublin South East

Locations

Saint John of God Intellectual Disability Services - Dublin South East

Dublin, Leinster, Ireland

Countries

Ireland

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Other Identifiers

ID2046

Identifier Type: -

Identifier Source: org_study_id