Group-based Resistance Training for Adults With Down Syndrome

NCT07347912 | Active Not Recruiting

• 1 other identifier: ID2046
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Healthy Aging; Resistance Training

Keywords

Dementia Risk Reduction; Proactive Intervention

Outcome Measures

Primary Outcomes (15)

• Episodic Memory

  Episodic Memory will be assessed using The FULD Object Memory Evaluation Test (FOME) which is a published standardized test. This test will be individually administered to each participant by the Research Assistant (RA) during their assessment sessions. The FOME has been found to be a reliable and valid measure of episodic memory (with reliability coefficients ranging from 0.91 to 0.96). It evaluates the episodic memory functions of encoding, storage, and recall across five recall trials (score range 0 to 50; higher scores indicating greater episodic memory) and a delayed recall trial (score range 0 to 10; higher scores indicating greater episodic memory). This scale will be completed by the participant during their assessment sessions with the RA. It is estimated that this measure will take about 10 minutes to complete.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Adaptive Behaviour

  Adaptive Behaviour will be measured using the Vineland Adaptive Behaviour Scales (3rd Edition). The Domain-Level Parent/Caregiver Form will be completed by Proxy participants during each assessment period. The Vineland Adaptive Behaviour Scales is a valid and reliable (Cronbach alpha scores range from 0.93 to 0.97) measure of personal and social skills needed for everyday living. It is widely used to assess the adaptive behaviour of adults with intellectual disabilities. It provides three standardised domain scores: communication (standard score range 20 to 140; higher scores indicating better communication), socialisation (standard score range 20 to 140; higher scores indicating better socialisation), and daily living skills (standard score range 20 to 140; higher scores indicating better daily living skills) and an overall adaptive behaviour composite score (standard score range 20 to 140; higher scores indicating better adaptive behavior. It takes about 10 - 15 minutes to complete.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Grip Strength

  Grip strength will be measured using a handheld Jamar® Smart Hand Dynamometer, an established tool for evaluating isometric grip force. Assessment will be administered by a registered Physiotherapist at SJOG-DSE. Estimated duration: \<5 minutes. Unit of Measure: Kilograms of force (kg). The higher the kg or force, the stronger the grip.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Mobility

  Mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time taken to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Administered by a registered Physiotherapist. Estimated duration: \<5 minutes. Unit of Measure: Seconds (s).

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Leg Strength

  Mobility will also be assessed using the Sit to Stand test, which measures the number of times a participant can rise from a chair to a full standing position within 30 seconds. Assessment will be administered by a registered Physiotherapist. Estimated duration: \<5 minutes. Unit of Measure: Number of repetitions in 30 seconds.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Blood Pressure

  Blood pressure will be measured using a calibrated sphygmomanometer in a seated position after 5 minutes rest. Blood pressure will be taken by a registered nurse. Estimated duration: \<5 minutes. Unit of Measure: Millimeters of mercury (mmHg). A healthy blood pressure is below 120/80 mmHg.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Body Mass Index

  BMI is a measurement of a person's leanness based on their height and weight, and is intended to quantify tissue mass. It is widely used as a general indicator of whether a person has a healthy body weight for their height. Specifically, the value obtained from the calculation of BMI is used to categorize whether a person is underweight, normal weight, overweight, or obese depending on what range the value falls between. Heigh (cm) and Weight (kg) will be measured by a healthcare professional. Unit of Measure: kg/m² Ranges: Underweight: BMI less than 18.5 kg/m². Normal weight: BMI between 18.5 and 24.9 kg/m². Overweight: BMI between 25 and 29.9 kg/m². Obese: BMI of 30 kg/m² or higher.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Resting Heart Rate

  Resting heart rate will be measured using a heart rate monitor after 5 minutes rest. This measure will be taken by a registered nurse. Estimated duration: \<5 minutes. Unit of Measure: Beats per minute (bpm). A lower resting heart rate generally indicates better cardiovascular fitness and a more efficient heart. Regular exercise and physical activity can lead to a lower resting heart rate over time.

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Attendance Rate

  Attendance will be recorded for each scheduled session. Unit of Measure: Percentage of sessions attended per participant

  Across all sessions during the initial programme (24 sessions over 12 weeks) Across all sessions during the crossover programme (24 sessions over 12 weeks)

• Session Satisfaction (Participant-Reported)

  Participants will rate their satisfaction at the end of each session using an adapted "easy read" 5-point Likert scale (0 = "No!" to 5 = "Yes, a lot!"). Higher scores indicate greater satisfaction. Unit of Measure: Score on 0-5 Likert scale (higher = greater satisfaction)

  Immediately after each session throughout the programme (24 sessions over 12 weeks Immediately after each session in the crossover phase (24 sessions over 12 weeks)

• Trainer-Reported Engagement Score

  Trainers will rate participant engagement across four domains: interest, communication, enjoyment, and mood. Each domain scored on a 0-4 scale. Higher ratings indicate more favorable interest, communication, enjoyment, and mood. Unit of Measure: Score per domain (0-4).

  Time Frame: Immediately after each session throughout the programme (24 sessions over 12 weeks) Immediately after each session in the crossover phase (24 sessions over 12 weeks)

• Resource Cost (Hours)

  Total hours required for program adaptation, planning, delivery, and evaluation will be recorded. Unit of Measure: Hours.

  Through study completion (approximately 18 months)

• Equipment costs in Euro €

  Total cost of equipment required to run the RT program. Each item will be itemized and costed individually and then totaled. Unit of Measure: Cost in Euros €.

  Through study completion, approximately 18 months.

• Recruitment Rate

  Recruitment rate will be calculated as the proportion of participants recruited from the total eligible pool, along with the average monthly recruitment rate. Unit of Measure: Percentage of eligible participants recruited.

  Approximately 4-6 months recruitment period.

• Retention Rate

  Retention rate will be calculated as the number of individuals that completed the follow-up measures as a proportion of those recruited. Unit of Measure: Percentage of recruited participants completing all assessments.

  Through study completion (approximately 18 months)

Secondary Outcomes (4)

• Subjective Wellbeing

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Memory Self-efficacy

  Baseline (1-2 weeks pre program) Post (1-2 weeks post program) 3-month follow-up (12-14 weeks post-program) Crossover Baseline (1-2 weeks pre program) Crossover Post (1-2 weeks post program) Crossover 3-month follow-up (12-14 weeks post-program)

• Rate of Perceived Exertion - staff rated

  Immediately after each exercise during each session throughout the programme (24 sessions over 12 weeks) Immediately after each exercise during each session in the crossover phase (24 sessions over 12 weeks)

• Adapted Rate of Perceived Exertion - participant self-rated

  Immediately after each session throughout the programme (24 sessions over 12 weeks Immediately after each session in the crossover phase (24 sessions over 12 weeks)

Study Arms (2)

Resistance Training

EXPERIMENTAL

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.

Behavioral: Resistance Training

Services as Usual Control Group

OTHER

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.

Other: Services as Usual Control Group

Interventions

Resistance Training 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.

Resistance Training

Services as Usual Control Group 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.

Services as Usual Control Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint John of God Intellectual Disability Services - Dublin South East: lead
• University College Dublin: collaborator

Study Sites (1)

Saint John of God Intellectual Disability Services - Dublin South East

Dublin, Leinster, A96 EA03, Ireland

Location

Related Publications (10)

• Benson T, Sladen J, Liles A, Potts HWW. Personal Wellbeing Score (PWS)-a short version of ONS4: development and validation in social prescribing. BMJ Open Qual. 2019 Apr 11;8(2):e000394. doi: 10.1136/bmjoq-2018-000394. eCollection 2019.

  PMID: 31206049 BACKGROUND

• Panel on Measuring Subjective Well-Being in a Policy-Relevant Framework; Committee on National Statistics; Division on Behavioral and Social Sciences and Education; National Research Council; Stone AA, Mackie C, editors. Subjective Well-Being: Measuring Happiness, Suffering, and Other Dimensions of Experience [Internet]. Washington (DC): National Academies Press (US); 2013 Dec 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK174473/

  PMID: 24432436 BACKGROUND

• Chung JC. Clinical validity of Fuld Object Memory Evaluation to screen for dementia in a Chinese society. Int J Geriatr Psychiatry. 2009 Feb;24(2):156-62. doi: 10.1002/gps.2085.

  PMID: 18612999 BACKGROUND

• FULD, P.A. The Fuld Object Memory Evaluation. Chicago: Stoelting Instrument Company, 1981

  BACKGROUND

• Sparrow, S. S., Cicchetti, D. V., & Saulnier, C. A. (2016). Vineland Adaptive Behavior Scales, Third Edition. Bloomington, MN: Pearson Assessment.

  BACKGROUND

• Weinberg, R. S., & Gould, D. (2015). Foundations of sport and exercise psychology (6th ed.). Champaign, IL: Human Kinetics

  BACKGROUND

• Pape SE, Baksh RA, Startin C, Hamburg S, Hithersay R, Strydom A. The Association between Physical Activity and CAMDEX-DS Changes Prior to the Onset of Alzheimer's Disease in Down Syndrome. J Clin Med. 2021 Apr 27;10(9):1882. doi: 10.3390/jcm10091882.

  PMID: 33925348 BACKGROUND

• Ptomey LT, Szabo AN, Willis EA, Gorczyca AM, Greene JL, Danon JC, Donnelly JE. Changes in cognitive function after a 12-week exercise intervention in adults with Down syndrome. Disabil Health J. 2018 Jul;11(3):486-490. doi: 10.1016/j.dhjo.2018.02.003. Epub 2018 Feb 26.

  PMID: 29501470 BACKGROUND

• Broadhouse KM, Singh MF, Suo C, Gates N, Wen W, Brodaty H, Jain N, Wilson GC, Meiklejohn J, Singh N, Baune BT, Baker M, Foroughi N, Wang Y, Kochan N, Ashton K, Brown M, Li Z, Mavros Y, Sachdev PS, Valenzuela MJ. Hippocampal plasticity underpins long-term cognitive gains from resistance exercise in MCI. Neuroimage Clin. 2020;25:102182. doi: 10.1016/j.nicl.2020.102182. Epub 2020 Jan 14.

  PMID: 31978826 BACKGROUND

• Weterings S, Oppewal A, van Eeden FMM, Hilgenkamp TIM. A resistance exercise set for a total body workout for adults with intellectual disabilities, a pilot study. J Appl Res Intellect Disabil. 2019 May;32(3):730-736. doi: 10.1111/jar.12552. Epub 2018 Dec 10.

  PMID: 30536559 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sharon Hardiman

  Saint John of God Intellectual Disability Services - Dublin South East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Efficacy data will be collected by the Research Assistant who will be blind to group membership. The Efficacy data will be anonymized by removal of any directly identifying component and the pseudonymizing "key" will be held by the PI.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Psychologist

Model Details: This is a pilot randomised control crossover trial study that will use a mixed methods approach to assess the feasibility and efficacy of group based resistance training (RT) for adults with Down syndrome attending a community based intellectual disability service. To mitigate the potential limitations of a small sample size, a crossover design will be employed meaning participants initially assigned to the services as usual control group will become experimental participants (and take part in the RT programme), after the first intervention group have completed their 3-month follow-up assessment. Accordingly, after the crossover, participants originally allocated to the experimental group will attend the remaining assessment sessions as services as usual participants.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 16, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)