Group-based Resistance Training for Adults With Down Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Episodic Memory — 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)
  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.
• Adaptive Behaviour — 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 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.
• Grip Strength — 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 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.
• Mobility — 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 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).
• Leg Strength — 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 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.
• Blood Pressure — 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 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.
• Body Mass Index — 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)
  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.
• Resting Heart Rate — 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 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.
• Attendance Rate — Across all sessions during the initial programme (24 sessions over 12 weeks) Across all sessions during the crossover programme (24 sessions over 12 weeks)
  Attendance will be recorded for each scheduled session. Unit of Measure: Percentage of sessions attended per participant
• Session Satisfaction (Participant-Reported) — 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)
  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)
• Trainer-Reported Engagement Score — 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)
  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).
• Resource Cost (Hours) — Through study completion (approximately 18 months)
  Total hours required for program adaptation, planning, delivery, and evaluation will be recorded. Unit of Measure: Hours.
• Equipment costs in Euro € — Through study completion, approximately 18 months.
  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 €.
• Recruitment Rate — Approximately 4-6 months recruitment period.
  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.
• Retention Rate — Through study completion (approximately 18 months)
  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.

Trial sites (1)

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