Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05918289 |
| Other study ID # |
52 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2022 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
Zhangzhou University China |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this randomized control trial study is to evaluate the effect of the happy aging
education program on active aging determinants, and quality of life among community-based
Muslim older adults compared with the control group who avail only health education.
Q1.• What is the effect of the BIHAAAP on physical, mental, and behavioral aspects of active
aging among community-dwelling older adults in the compression to the control group who only
avail health education? Q2. What is the effect of the BAAEP on the quality of life among
community-dwelling older adults in Pakistan?
Treatment: (1) Face-to-face: 6 days, (2) home-based 12 weeks.
1. Face to Face: (1) Orientation, the aging process, the importance of exercises in old
age, coping strategies, and the beneficial effects of body movements in Muslim prayers.
(2) Hands-on training regarding proper body movement in Muslim five-time prayers.
2. Home-based treatment: (1) A Pictorial booklet consisting of tips to spend happy life in
old age and a workbook to complete. (2) Audio video recorded by a physiotherapist on the
proper body movements in five-time prayers to follow at home shared through whats app
number of at least one family member if the person does not have a smartphone.
Comparison group: One-day orientation. After the trial, the control group availed of the
booklet and video-recorded Muslim prayers-like exercises.
Description:
Road Map of the Study Development of BAAEP Development of content for face-to-face training
consisted of lectures, group activities, and hand on practice with the intention to improve
physical, mental, cognitive, and behavioral approaches for active aging.
Booklet contents: Tips on mindfulness eating habit practice to mentally prepare for any food
items before eating, positive thought generation practice by different scenarios, benefits of
exercises in pictorial form, pictures of healthy couples and beneficial effects of
relationships, tips for spiritual health, and the booklet contents homework after each
session.
Video development Detail about Muslim prayers like exercises
- Prepared guidelines from two published papers along with comprehensive descriptions
regarding each picture to develop a video on the mimic Muslim prayer's body movements'
video for home practice.
- Appointment of a physiotherapist holding a Masters's degree and practicing as a
physiotherapist in a private rehabilitation center, the checklist was shared to
practice.
- The physiotherapist will develop an outline to develop a video and will arrange a
meeting with other two physiotherapists, one doctor, and one community health nurse. The
major focus was to assess any restrictions for elders with any disease. The
physiotherapist will develop a video by adding instructions in the local language.
- A series of movements consisting of body parts movement starting from deep two deep
breaths.
- Movement of neck, shoulders, hands and arms, head, feet, and every joint of the body. It
will take only 10 to 15 minutes. The structured exercise steps follow all the steps
mentioned in the traditional Islamic prayers and yoga breathing. The detail of the
Muslim Salat-like exercise is mentioned below
- 1: Standing and Takbir: Takbir, is the movement of raising hands to the level of one's
face so that the thumbs touch the ear lobule, by doing that taking one deep breath,
precedes another prayer posture.
- 2: The Standing (Qiyam): Fundamental standing position for up to 60-90 seconds, with
some exceptions such as wrapping the arms in front of the belly in such a way that the
scapula is slightly retracted, taking two deep breaths. The chin is tucked in and the
person looks at his feet while standing, resulting in flexion at the upper cervical
spine, thus activation of the deep neck flexors, which are prone to getting weak as in
upper cross syndrome[50].
- 3: Rukuk: The bowing, or Rukuk, is a very important position biomechanically in which
forward bending occurs at the thoracic and lumbar spines, which leads to the stretching
of the Para spinal muscles and structures. The trunk and the lower extremity are at an
approximately 90-degree angle to each other. The person attempts to look between his
toes while adopting this position, which results in the activation of deep neck flexors,
which are usually prone to getting weak. The hip joint is in flexion, the knees are
extended, and the ankle is at 90° with the lower leg as in standing. The shoulders are
slightly flexed and the elbows are fully extended, whereas the hands rest on the knees.
The average duration of a Rukuk may last up to 10-15 seconds along
- 4: Prostration ( Sajdah): The prostration posture of Salat is similar to a fetus's pose,
and flexion occurs at the thoracic and lumbar spines, accompanied by hip flexion. The
knees are in mid-flexion, the ankle is in the neutral position, and the toes are
extended. The shoulders are slightly abducted, the elbows in mid-flexion, and the wrists
extended with the palms parallel to the ears. The lower cervical spine is also slightly
extended during prostration. It strengthen the triceps brachii and showed the greatest
activation. Triceps brachial activation in Salah was also significantly higher than in
the child's pose.
- The Sitting (Tahiyyat/Jalsa) Posture of Salat: The sitting (taqiyya) two-time head
position involves sitting on the floor with the lumbar and thoracic spines in neutral,
the hip joint in flexion, and the knee joint in full flexion for up to 30-60 seconds.
This results in a stretching of the quadriceps Femoris muscle. The hands are placed on
the distal aspect of the anterior thigh, with shoulders flexed and elbows extended,
though the full extension is not present, along with slight extension at the wrists.
- Turning of head side by side: Cervical exercises. Turns the head to both shoulders fit
right and then left.
Study Area: Study setting: Two residential areas of Peshawar, Khyber Pakhtunkhwa
1. Sample selection process: Lady health workers (LHWs) will be approached through the
District health office Peshawar and identified households with elders aged> 60 years
from the family registration registers of each LHW.Identified 300 older adults in the
jurisdiction of haji camp, skandertown, and Tarnab form.
Conduct a general health awareness program for all elders who registered with the five
LHWs and will be given the responsibility of monitoring elders to perform exercises in
their homes. A convenient sampling method will be used to recruit some of the elderly in
the two regions of Peshawar in Khyber Pakhtunkhwa province.
2. Recruitment of the participant 2.1. Sample size calculation: Sample size will be
calculated using G-power by priori power analysis. An effect size of 0.83 will be used
from a previous study conducted on technology-based elder education. The sample size
calculation will assume (i.e. α =0.05, power=0.8. Total 140.
2.2. Screening for eligibility: We will conduct a health awareness program in three high
schools at different times in which around 300 elders participated. Arranged three
points in which all elders were checked for cognitive, activity, auditory, and visual
impairment levels.
2.2.1. Preliminary screening: screening will be conducted by physiotherapists and
community health nurses for frailty, and severe health problems for example cardiac
problems, cognitive problems auditory and severe visual problems (referred to
psychologist, ENT specialist, and family medicines doctor.
2.2.2 Secondary screening: To register for trial the screening will be taken to take (
consent, registration, baseline assessment for sedentary lifestyles who reported
spending less than 20 to 30 minutes per week outside in their home in the past month.
2.3. Sampling technique= Computer generated sequence will be employed to randomize study
subjects either to intervention or control group and then a web-based data management
system using a permuted block algorithm (with random block lengths) stratified by sex.
2.4. Treatment group=70, Control group=70 2.5. Treatment group= BAAEP, C= Usual
activities Participants included: (a) sedentary retired adults aged 65 and older who
reported spending less than 20 min per week in the past month
3. Procedure for implementation of treatment/ intervention 3.1. face: Three
trainers(physiotherapist, community health nurse, psychologist) conducted the
face-to-face sessions after getting training and piolet study. A PowerPoint presentation
was prepared according to the protocol. piloting was done in the same setting to modify
the discrepancies after taking feedback.
The setting was checked for ventilation, temperature, lighting, and chairs. 3.1.1. Setting
for intervention: Three government high schools and one private high school were allocated
for the training sessions by taking approval from the district education officer and the
honor of a private school.
3.1.2. Three volunteers will be assigned for the setting and technical support through proper
agreement. The generator was arranged for power backup during the session.
3.13.3. Interventions process: Orientation and three sections (1) didactic such as giving
information and knowledge regarding aging, challenges and positive aspects of aging),(2)
group activity for positive thinking, joke as an energizer, discussion on hobbies and
interest,(3) hands-on training for( mind fullness and prayers like proper body movements
exercises. Each group consisted of 15 participants, five-session in a day and each group
availed 90 minutes sessions per week.
During the session continue feedback will be taken from the participants regarding any
difficulty in performing exercises, understanding level, and further suggestions.
3.13.Transforming from face-to-face sessions to home-based training
- Make a list of the WhatsApp numbers of each participant
- Research group will share the videos one by one with their numbers
- Booklets will be distributed and take signatures and kept records for both video and
booklet distribution.
- Lady heath visitors along with the research team will be responsible to make sure of the
implementation at home and recording any adverse effects. Reporting and referring forms
were developed and given to the research team for recording.
Quality control: Homogeneous population characteristics; both male and female; data
collectors and data analysts will be kept unaware of the research intention.
Participants were not blind due to the ethical considerations of the study. Researchers were
not directly involved in the session and only observed the ongoing process, the researchers
were not involved in the data collection process only randomly checking the objectivity, and
researchers were not directly involved in data analysis to prevent biases. A person who will
be unaware of the purpose of the study performed randomization of the total 140 elders in two
groups. The research team was not aware of the outcome variables and was not involved in the
data collection task. The data collectors were kept blind from the intervention strategies.
The study protocol is approved by the School of Nursing, Zhengzhou University. Written
approval was taken from the School of Nursing, ZZU, and from the local health department of
Khyber Pakhtunkhwa. Approval was taken from the local government of the province along with
the readiness of the research teams and area representatives for conducting the session
inside their premises of the area.
All participants were informed about the study and a written approval of willingness was
taken from all the participants. In addition, their personal details are kept secret by
assigning ID numbers and did not be used for any other purposes and this was well ensured.
