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临床试验/NCT07164508
NCT07164508尚未招募不适用

Revolutionizing Adapted Physical Activity for Individuals With Physical Disabilities: Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area

Education University of Hong Kong1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
225
试验地点
1
主要终点
Physical fitness - Physical health outcome - Muscular Strength

研究概览

简要总结

The present study builds on the promising result of our SLVB pilot study with the aim to extend the works' impact by investigating the effectiveness of a SLVB intervention on the physical and psychological health outcomes in adults with physical disabilities in HKG by collecting quantitative and qualitative data in a larger sample (225 participants). The investigators hypothesize that the SLVB and Seated Dance (SD) interventions will improve physical and psychological health outcomes, and quality of life compared to the control group, with SLVB expected to be more effective than SD in enhancing health outcomes for PWPDs. Using the consolidated evidence on the benefits of SVLB from our research work, the investigators will promote SLVB in HKD and CHN by organizing i) train-the-trainer workshops (325 trainers trained), ii) SLVB classes (about 1270 PWPD in HKG and CHN) and iii) SLVB competitions in HKG and CHN (initial rounds of competition will be held across Hong Kong, Shenzhen and Guangzhou, with the finals to be held in Hong Kong, totaling to 408 participants). The investigators combine the evidenced benefits of SVLB with the Train-The-Trainer approach, suggested by the World Health Organization, to achieve community engagement and it is regarded as a solution to institutional barriers in promoting adapted physical activity. SLVB teaching aids will also be developed to promote the activities.

详细描述

One hundred and thirty-eight participants will be randomly assigned into the SLVB, Seated Dance (SD), and control groups in a 1:1:1 ratio. Outcome assessors will be blinded to treatment allocation. Data will be collected at baseline (pretest), after a 16-week intervention (posttest), at 3 months and 6 months after the intervention. Both the SLVB and SD intervention programmes consist of 32 training sessions, with 2 x 75- min sessions per week. The duration of the proposed intervention is consistent with the recommendation of World health Organization. The SLVB intervention programme will be based on our previous SLVB programme specifically designed for PWPD. Programme content will include SLVB basic skills and posture, basic team tactics, and rules and regulations. In the SD group, participants will learn freestyle para dance in sessions, including hip-hop and Latin dance. They will learn step sequences of increasing complexity in a seated position, and music will then be added. Participants in the control group will be instructed to maintain their normal daily activity and asked to join monthly non-exercise social gatherings (e.g., health talk) to balance the psychosocial effect of the regular gatherings in other groups. Inclusive criteria for participants will be (a) aged ≥18 years; (b) PWD registered in the Central Registry for Rehabilitation; (c) diagnosed with physical disabilities such as impaired muscle power, limb deficiency, or leg length difference, using the SVB and Para dance classification of International Paralympic Committee; (d) with at least one functional arm; (e) with a normal to mild grade intellectual disability; (f) have not participated in a structured PA programme during the 6 months preceding the study; and (g) can communicate in Chinese. The Mini-Mental Statewill be used to screen for abnormal cognitive function; the Berg Balance Scale will be used to screen for participant's sitting balance ability. Participants who a) record an MMSE score ≤ 17; b) are unable to sit unsupported [balance score ≤ 2 (i.e., sit 30 seconds)]; c) Body Mass index (BMI) ≥ 27; d) have had orthopaedic surgery 6 months prior to the study entry; e) have a history of cardiovascular disease that hinders study participation; f) have seeing and/or hearing difficulties; g) have not been approved by his/her physician to participate in the study due to a limiting medical condition, will be excluded from the study. Based on a more conservation effect size (Cohen's d = .6) from the physical attributes of our previous SLVB intervention study, a total sample of 111 PWPD (with 20% expected dropout rate) is required in this study to achieve power of 80% at p ≤ .05. The investigators, therefore, aim to recruit a total sample size of 138 participants (46 participants per NGO serving PWPD, 3 NGOs are needed) and allocated in a 1:1:1 ratio into SLVB, SD and control groups (15-16 participants in each arm in each NGO). Procedures. Participants will be recruited through recruitment talk(s) conducted by the research team and by advertisements in the partnered NGOs. First, an initial information session will be delivered to groups of potential participants by providing them with intervention details and distributing the informed consent statement. After obtaining the participant's signed informed consent, data collection will be conducted by the SRA and trained student helpers. Before the pretest, participants will undergo screening tests such as MMSE. In addition to completing questionnaires, participants will begin by taking fitness and other tests according to the standardized testing protocol. Next, an independent researcher, not otherwise involved in the study, will use a computer-based random number generator to randomly assign participants into SLVB, SD, or control groups. The intervention will begin next week. Participants will complete a posttest and follow-up tests upon completion of the 16-week intervention, 3 and 6 months after the intervention, respectively, using procedures identical to those described for the pretest measurements. The independent evaluators assessing the participants' outcomes and individuals performing data entry and data analysis will be blinded to group assignment.

Measures (Primary - Physical health outcomes) i. Physical fitness. The Brockport physical fitness test will be used to measure the physical fitness of participants. The fitness tests include a grip test (upper body muscular strength), dumbbell press test (upper body muscular endurance), skinfold test and body mass index evaluation (body composition), and shoulder stretch test (flexibility). Submaximal arm ergometry test, six-Minute Arm Test will be used to measure participant's aerobic endurance. The validity and reliability of the above tests have been confirmed for use with PWD and it has been used in HK.

ii. Sitting balance. A modified Functional Reach Test will be used to assess limits of stability by measuring the maximum distance that an individual can reach forward and laterally while sitting in a fixed position. Its reliability and validity have been supported for adults with disabilities.

iii. Anticipation time. A Bassin Anticipation Timer (BAT, Lafayette Instrument Company, Model 35575) will measure the participant's visual acuity related to eye-hand coordination and anticipation (in milliseconds.). Using BAT devices, participants will be instructed to press a button to coincide with light arrival at the target.

Measures (Secondary - Psychological health outcomes) i. Quality of life (QoL). QoL will be measured using a shortened version of the SF36 Health Survey (SF-12). Reliability and validity have been evaluated in Chinese. SF-12 comprises eight domains such as mental health, social, and physical functioning …etc.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Independent evaluators assessing participants' outcomes, and those involved in data entry and analysis will be blinded to group assignments.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People with disabilities registered in the Central Registry for Rehabilitation.
  • Diagnosed with physical disabilities such as impaired muscle power, limb deficiency, or leg length difference, using the soft volleyball and Para dance classification of International Paralympic Committee.
  • Has at least one functional arm.
  • With a normal to mild grade intellectual disability.
  • Have not participated in a structured physical activity program during the 6 months preceding the study.
  • Can communicate in Chinese.

排除标准

  • Having a recorded Mini-Mental State Examination score of 17 or below.
  • Unable to sit unsupported, by recording a balance score at or below 2 on the Berg Balance Scale (indicating they are able to sit for a maximum of 30 seconds).
  • Having a Body Mass Index of 27 or above.
  • Have had orthopedic surgery 6 months (or less) prior to the study entry.
  • Have a history of cardiovascular disease that hinders study participation.
  • Have seeing and/or hearing difficulties.
  • Have not been approved by his/her physician to participate in the study due to a limiting medical condition

结局指标

主要结局

Physical fitness - Physical health outcome - Muscular Strength

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

The Brockport Physical Fitness Test will be used to assess multiple components of physical fitness in participants. This includes Upper Body Muscular Strength: Assessed using the Grip Test, reported in kilograms.

Physical fitness - Physical health outcome - Muscular Endurance

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

The Brockport Physical Fitness Test will be used to assess multiple components of physical fitness in participants. This includes Upper Body Muscular Endurance. it will be assessed using the Dumbbell Press Test, reported as number of repetitions.

Physical fitness - Physical health outcome - Body Composition - Body Mass Index

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

The Brockport Physical Fitness Test will be used to assess multiple components of physical fitness in participants. This includes Body Composition. Body Mass Index. Weight and height will be combined to report BMI in kg/m\^2.

Physical fitness - Physical health outcome -The Brockport Physical Fitness Test

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

The Brockport Physical Fitness Test will be assessed using the Skinfold Test (reported in millimeters)

Physical fitness - Physical health outcome - Flexibility

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

The Brockport Physical Fitness Test will be used to assess multiple components of physical fitness in participants. This includes flexibility, assessing using the Shoulder Stretch Test, reported as pass/fail based on reach criteria.

Physical fitness - Physical health outcome - Aerobic Endurance

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

The Brockport Physical Fitness Test will be used to assess multiple components of physical fitness in participants. This includes Aerobic Endurance. It will be assessed using the Submaximal Arm Ergometry Test and the Six-Minute Arm

Anticipation time - Physical health outcome

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

A Bassin Anticipation Timer (BAT, Lafayette Instrument Company, Model 35575) will measure the participant's visual acuity related to eye-hand coordination and anticipation (in milliseconds.). Using BAT devices, participants will be instructed to press a button to coincide with light arrival at the target.

Sitting balance - Physical health outcome

时间窗: Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.

A modified Functional Reach Test will be used to assess limits of stability by measuring the maximum distance that an individual can reach forward and laterally while sitting in a fixed position. Its reliability and validity have been supported for adults with disabilities.

次要结局

  • Quality of life - Psychological health outcome(Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.)
  • Physical Activity Enjoyment - Psychological health outcome(Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.)
  • Mindful self-care - Psychological health outcome(Collected pre-test, post-test after 16 week intervention program, at 3 months after intervention and at 6 months after intervention.)

研究者

发起方
Education University of Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

LEUNG Ka Man Carman

Associate Professor, Principal Investigator

Education University of Hong Kong

研究点 (1)

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