Effects of Guided Exercise on Functional Performance and Independence in Adults With Intellectual Disability

NCT04616638 | Completed

• 1 other identifier: 1165646-7
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Adults with intellectual disabilities (ID) have significantly lower levels of fitness compared to the general population. The health benefits of enhanced muscular strength in the general population are well established. In adults with ID, increased muscular strength levels are positively associated with improved aerobic capacity and performance of functional tasks. A concerted effort has been made to design and evaluate resistance training (RT) interventions aimed at increasing muscular strength in adults with ID. While the findings are encouraging, the small number of published studies, missing or poorly described theoretical frameworks or familiarization protocols that guided the RT interventions, and compromised methodological quality raise questions about the actual effects of these interventions and warrant further investigation. The primary purpose of this study is to design and pilot test the effects of an innovative community-based multi-component RT program, Resistance Training for Empowerment (RT-POWER). The primary aim of RT-POWER is to improve muscular strength and independent functional performance in adults with ID. The trial is guided by the SCT theoretical framework. Adults with ID will be randomly allocated to either an experimental group (EG) or a control group (CG). The EG will receive the RT-POWER intervention and the CG will receive an RT intervention traditionally used with the general population. Stage 1 will consist of six familiarization sessions (2 per week for 3 weeks) and Stage 2 will consist of 20 RT sessions (2 per week for 10 weeks). Five hypotheses will be tested: (a) The EG will demonstrate significantly greater increases on the chest-press and leg-press one-repetition maximum (1-RM) tests from baseline to Week 15 compared with the CG; (b) The EG will demonstrate significantly greater increases on the plank test from baseline to Week 15 compared with the CG; (c) The EG will demonstrate significantly greater increases on the six-minute walk test (6MWT) from baseline to Week 15 compared with the CG; (d) The EG will demonstrate significantly greater decreases on the stair climb functional test (SCFT) from baseline to Week 15 compared with the CG; and (e) The EG will demonstrate significantly greater increases in the percentage of steps performed correctly and independently of four RT exercise tasks from baseline to Week 15 compared with the CG.

Conditions

Intellectual Disability; Exercise; Obesity

Keywords

Functional performance; Intellectual disability; Resistance training; Social cognitive theory

Outcome Measures

Primary Outcomes (5)

• Change in dynamic upper-body and lower-body strength

  Upper-body and lower-body muscular strength will be measured with the chest-press and the leg-press 1-RM tests (ACSM, 2018), respectively. Each testing session will start with a warm-up set of 6-10 repetitions, with approximately 50% of the estimated resistance. Loads will be estimated with the repetitions-to-fatigue method. Participants will be given 3 attempts. For each attempt, participants will be asked to complete 2 repetitions at the same speed of movement and range of motion. If a participant completes 2 repetitions, the resistance will be increased by 3-10% in the next attempt (or decreased by 3-10% if the first attempt is not successful). This same procedure will be used for the third attempt. The final weight lifted successfully with only one repetition will be recorded to the nearest 5 lb. The rest period will be 3-5 min between the attempts and 5 min between the exercises. Both tests have been used in other clinical trials with adults with ID (Shields et al., 2008).

  Change from Baseline to Week 15

• Change in static trunk strength

  The prone plank test will measure static trunk strength (ACSM, 2018). After taking shoes off, the participants will be asked to assume the forearm plank position with elbows in contact with the ground, the humerus forming a perpendicular line to the horizontal plane, and the forearms in the neutral position with hands directly in front of the elbows. The timer will start once participants assume a rigid anatomical body position so that only their forearms and toes supported the body. Participants will hold this position as long as possible, and the test will be terminated when the participants voluntarily stop the test, fail to maintain the position, or report ill effect from the test. The total time to hold the position will be measured to the nearest 0.01 s. The best of two trials (30 s between trials to rest) will be used for analysis. The test is a valid and reliable measure for evaluating trunk strength in both younger and older adults (Bohannon et al., 2018).

  Change from Baseline to Week 15

• Change in cardiopulmonary functional capacity

  Two measures of functional performance were used in this study. The Six-Minute Walk Test (6MWT; American Thoracic Association, 2002) is a submaximal field test of cardiopulmonary functional capacity for activities of daily living (Enright \& Sherrill, 1998). The test will be performed using a 50-ft course in the gym. Participants will be instructed to walk as fast as possible for 6 min without running or jogging. During the first lap, a research assistant will walk behind the participant, and then provide standardized encouragement every minute (Casey et al., 2012). The distance walked in 6 min will be measured to the nearest cm. The 6MWT is a reliable (ICC = .96) and a valid test for assessment of cardiorespiratory fitness in adults with mild to severe ID, with strong relationships with VO2 peak and isometric leg strength (Guerra-Balic et al., 2015).

  Change from Baseline to Week 15

• Change in functional mobility

  The Stairs Climb Functional Test (SCFT; Nightingale et al., 2014) assesses ability to ascend and descend a flight of stairs and lower extremity strength, power, and balance. Participants will be instructed to as quickly as possible ascend, turn, and descend 10 stairs (about 25 cm deep and 16.5 cm high) using any method of traversing the stairs but to take one step at a time and not use the handrails for support. The total time to ascend and descend stairs will be measured to the nearest 0.01 s. The best of three trials (30 s between trials to rest) will be used for analysis. The SCFT is a valid measure of functional mobility in adults with different diagnoses (Nightingale et al., 2014).

  Change from Baseline to Week 15

• Change in performance of RT exercise tasks

  The performance of four RT exercise tasks (i.e., chest press, leg press, seated row, and military press) will be assessed. A Sony Handycam camcorder will be used to record performance of each exercise task. To observe and code exercise performance, Obrusnikova et al. (2020) and Obrusnikova et al. (2019) developed a coding manual for the four exercise tasks following guidelines proposed by Yoder and Symons (2010). According to the coding manual, a participant's response was considered correct if the performed step conformed to the description in the task analysis (quality), was initiated within 8 s of the exercise directive or completion of the previous step in the task sequence (latency), and was completed within 15 s (duration). The coding manual was piloted and used in previous studies with adults with ID (Obrusnikova et al., 2020; Obrusnikova et al., 2019). To ensure coding reliability, inter-observer agreement (IOA) checks will be completed for all observational data.

  Change from Baseline to Week 15

Study Arms (2)

RT-POWER Intervention

EXPERIMENTAL

Six familiarization sessions and 20 RT-POWER sessions.

Behavioral: Resistance Training for Empowerment (RT-POWER)

Control Intervention

ACTIVE COMPARATOR

Six control familiarization sessions and 20 traditional RT sessions.

Behavioral: A traditional RT intervention

Interventions

Resistance Training for Empowerment (RT-POWER) BEHAVIORAL

The EG intervention was designed using the Social Cognitive Theory and its four sources of self-efficacy to promote a participant's (a) involvement in exercise planning, (b) muscular strength, and (c) independent functional performance. It consisted of three phases, which were adapted from the Self-Determined Learning Model of Instruction (Wehmeyer et al., 2000). This model draws from theory and research on self-management and self-control (Bandura, 1986; Martin et al., 1988). Participants were taught by their coaches how to (a) set a goal to meet fitness needs (Phase 1), (b) make a plan to meet goals (Phase 2), and (c) adjust actions to complete the plan (Phase 3).

RT-POWER Intervention

A traditional RT intervention BEHAVIORAL

The control intervention also consisted of a three-phase instructional process. Consistent with traditional RT interventions (ACSM, 2009), the coaches rather than the participants, were the primary agents for goal-setting, exercise planning, goal attainment monitoring, and readjusting of the exercise plan. Neither the visual activity schedules nor the system of least-to-most prompts was used in this intervention.

Control Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• an IQ score below 70;
• a chronological age between 18 and 44 years;
• a receptive vocabulary score at or above five years of age;

You may not qualify if:

• previous diagnosis of any chronic or co-morbid condition that could affect the performance of the target exercise tasks as assessed by the AHA/ACSM Health/Fitness Facility Preparticipation Screening Questionnaire (ACSM, 2014);
• a record of currently being pregnant or undergoing hormonal replacement or cancer therapy;
• prior or current experience with a similar intervention.

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Intellectual Disability; Motor Activity; Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

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

• Iva Obrusnikova, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 5, 2020
• Study Start: January 17, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)